philips m5071a recall

Please refer tothe FDAs guidance on continued use of affected devices. Philips - M5071A HS1 Adult SMART Defibrillator Pads Cartridge $75.00. During the recertification process for replacement devices, we do not change the device serial number or model number. Please review the DreamStation 2 Setup and Use video for help on getting started. No. If you do not have a spare pads cartridge, attend to the patient, Philips has an updated Adult SMART pad and expects to submit for clearance by Competent Authorities globally. Keep a copy of your letter with the Instructions for Use/Owners Manual of your HS1/OnSite/Home AED. If no spare set is available, perform CPR until Emergency Medical Services Personnel arrive. What you need to know To replace your pads, locate the latch at the top edge of the AED and slide it to the side. Susceptibility to Degradation and Volatile Organic Compound Emission . Once Competent Authorities clear the updated Adult SMART pads and Philips has received verification of your AED serial number and current Adult SMART pads LOT#, you will be provided with an updated Adult SMART Pad cartridge. It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. Further testing and analysis on other devices is ongoing. No. With the comprehensive test and research program for affected CPAP/BiPAP sleep therapy devices now complete, we asked him about whats changed since the start of the recall, what the test results mean for patients, and what to expect from Philips Respironics in the future. A patient no longer needs to tap a Ramp button every night to start at the desired pressure. The guidance for healthcare providers and patients remains unchanged. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. If the current Adult SMART pads cartridge is not expired, please keep it as a spare to use in an emergency only. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/Owners Manual and the Letter/Field Safety Notice. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. Is there a safety hazard with these devices? Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE The issue described in the Field Service Notice does not affect the Philips FRx device and pads. Prompts are repeated and rephrased if needed and include additional instructions to aid understanding. What should I do if I have permanently taken my HS1/OnSite/Home AED out of service? Product. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). The potential issue is with the foam in the device that is used to reduce sound and vibration. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. [FOR WEB] Please scroll down to view photos of affected devices if you are unsure which device you currently use. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE. Do not open the pads to check. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Sound Abatement Foam . Replacing your HeartStart AED Pads | Philips The AED will audibly guide users through each step of the procedure. (Most of these reports, approximately 80, were received in 2021.) 1 Take out the new SMART Pads cartridge from its package. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected. Are there substitute pads or other brands that can be used with the device? About Us; Blog; Please be sure to check philips.com/src-update for the latest information on remediation progress. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. Philips lmnar inga utfstelser eller garantier av ngot slag med avseende p tredje parts webbplatser eller informationen dri. Once we have clearance, we will begin providing updated Infant/Child SMART pads. In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patients skin. Serial numbers are not continguous. There is also the potential for delayed therapy, if the appearanceof the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads. PDF Product Defect Correction - Philips Any HS1/OnSite/Home AED pad (PN:M5071A, M5072A) currently installed in or stored with an HS1/OnSite/HomeAED could experience this issue. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/OwnersManual. What has Philips done to correct the issue? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips Quick Reference, HS1 English $6.00. Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II. During use, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. By returning your original device, you can help to make sure that it can be repaired for future use by another patient. It is important that you do not stop using your device without discussing with your doctor. Alla rttigheter frbehlles. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Adult and pediatric pads for HS1/OnSite/Home AEDs are still shipping. PleaseretainacopywiththeequipmentInstructionforUse. Philips Respironics Sleep and Respiratory Care devices, new devices and repair kits produced to meet the U.S. registration demand*, devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Owners or users of DreamStation 1 devices who wish to preserve their units for purposes of a lawsuit have the option of requesting preservation, either by Philips Respironics or by the user, through the Preservation Registry established by Philips Respironics. Where to find the LOT #: Once you receive the updated Adult SMART pads cartridge, replace the current pads cartridge in your AED with the new one. The SMART pads cartridge will be released. Please contact your local Philips representative. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. This URGENT Medical Device Recall Letter is intended to . What should customers do if there seems to be something wrong with a pads appearance? The affected products are identified in the tables below: DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay of therapy if the user hesitates to apply the pad due to its appearance. Philips Heartstart OnSite AED Pads-M5071A This Adult SMART pads cartridge for Philips OnSite AED are appropriate for cardiac arrest victims weighing 55 pounds or more. To read more about ongoing testing and research, please click here. Out of an abundance of caution, a reasonable worst-case scenario was considered. PDF M5071A Adult SMART Pad Cartridge Replacement Procedure Form - Philips Any pad currently installed in or stored with an HS1 AED could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. URGENT - Medical Device Recall Product: Date: Subject: Philips M5071A (adult) and M5072A (infant/child) AED pads March 2, 2022 . Owners or users of DreamStation 1 devices who wish to preserve their units for purposes of a lawsuit have the option of requesting preservation, either by Philips Respironics or by the user, through the Preservation Registry established by Philips Respironics. It is also possible that the gel could separate almost completely from the foam/tin backing when peeled. area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. This replacement reinstates the two-year warranty. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Call Us on Please call 514-738-6551. Philips M5071A Smart Adult Electrode Cartridge for - WebstaurantStore Only devices affected by the recall/ field safety notice must be registered with Philips. We are always interested in engaging with you. This URGENT Medical Device Recall Letter is intended to . The replacement pads also show the proper placement for the lay responder for crucial, faster application times. This Philips Respironics December 2022 update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for VOCs, particulate matter (PM), and other testing such that healthcare providers have additional information to make informed decisions regarding the risk of continued use of recalled products. When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Purchase your Philips HeartStart pads today. If the problem occurs and you do not have a spare pads cartridge, attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive. Out of an abundance of caution, a reasonable worst-case scenario was considered. Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. Philips has identified that for affected pads, some gel may fold onto itself, resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad to make contact with a patients skin. Opened or dried pads cannot be used in an emergency. Please click here for the latest testing and research information. Philips HeartStart OnSite Trainer Accessories, Philips HeartStart FRx Trainer Accessories, Cardiac Science Powerheart AED G3 Plus Accessories, Cardiac Science Powerheart AED G5 Accessories, Cardiac Science Powerheart G5 Trainer Accessories, Physio-Control LP 1000 Trainer Accessories, URGENT - Medical Device Recall on Philips OnSite AED SMART pads cartridges, HS22005R / FSN-2021-CC-EC-012 Recall Notice, HS22005R / FSN-2021-CC-EC-012 - Recall Notice (Franais), Philips OnSite Adult SMART Pads Cartridge, Philips OnSite Infant/Child Cartridge Electrode Pads. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. . Philips has an updated Infant/Child SMART pad and expects to submit for clearance by Competent Authorities. No, this issue only affects Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1 Automated External Defibrillator (AED) devices. Please provide a copy of the Field Safety Notice letter with the new owner. Should I store a spare pads cartridge with my HS1/OnSite/Home AED? You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. In some cases, this foam showed signs of degradation (damage) and chemical emissions. The Philips Heart Start Home and On-site AED Defibrillator Replacement Battery can be used as a spare or replacement battery for the Philips Heart Start Home and On-site AED Defibrillators. Genom att klicka p lnken kommer du att lmna den officiella Philips Electronics Ltd. ("Philips") webbplats. Please click here for the latest testing and research information. If I use the AED, can I put the current pads back in for use? Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. As part of the remediation, we are offering repair or replacement of affected devices free of charge. As we have previously noted in connection with the return of your DreamStation device, we will not be returning DreamStation devices back to the original user. In December 2022, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. Radiography - X-ray & Fluoroscopy Solutions, Philips M5071A (adult) and M5072A (infant/child) AED pads, Important information for the continued safe and proper use of your equipment. No, this issue only affects Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1 Automated External Defibrillator (AED) devices. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English. We do not offer repair kits for sale, nor would we authorize third parties to do so. Class 2 Device Recall Philips, HEARTSTART, INFANT/CHILD SMART PADS Just follow these simple steps: Unlock the old cartridge by sliding the latch on top of the AED; Remove the old pad cartridge and discard; Insert the new Philips HeartStart OnSite replacement pads, m5071a, and snap into place. No, this issue does not affect the Philips indemnification obligation to users. Repair kits are utilized in the rework process to create a recertified unit. We have noticed an issue with a Philips M5071A (adult) and M5072A (infant/child) AED pads that, if it were to re-occur, could potentially pose a risk for the patient, user and/or bystanders. or where there is not a significant probability of serious adverse Since then, he has led the organization through the voluntary medical device recall of certain CPAP, BiPAP and Mechanical Ventilator devices. Instructions for Downloading Viewers and Players. Has this issue been reported to the FDA or other regulators? You can view a short video showing how to replace the pads cartridge at the following web address. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. The HeartStart HS1, OnSite andHome AEDs are intended for use in public places or the home. A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay of therapy if the user hesitates to apply the pad due to its' appearance. Further testing and analysis on other devices is ongoing. All rights reserved. PDF Recall for Product Correction Medsafe copy - Philips Lift out the used pads cartridge. Please make a note of the Serial Number(s) of your HS1/OnSite/Home AED(s) and contact Philips or your local Philips Representative who will be able to tell you to whom the notification was sent. If this occurs, the HS1 AED could deliver less effective or ineffective therapy. Once you receive the updated Adult SMART pads cartridge, replace the current pads cartridge in your AED with the new one. Using packing tape supplied, close your box, and seal it. The foil seal on the pads cartridge should be opened only for patient use in an emergency because the pads will quickly dry out if the foil seal is broken. As a first step, if your device is affected, please start the registration process here. You are about to visit a Philips global content page, 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam. No. View All Products. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. An expiration date is marked on the front of the pads cartridge. However, if the user is not in the Preservation Registry and fails to return his or her unit, then Philips may charge the users DME supplier for the cost of the replacement device. Do not hesitate to apply discolored, melted pads to the patient unless the gel has almost completely separated from the backing. What happens when Philips receives recalled DreamStation devices? What should customers do if there seems to be something wrong with a pads appearance? SKU: M5071A Individual Package Quantity: 1 ( ) Shipping: . These repair kits are not approved for use with Philips Respironics devices. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Will I be charged or billed for an unreturned unit? At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. IMPORTANT NOTE: The issue described in the Field Service Notice does not affect the FRx device and pads. I/we will forward all the recall information to the suppliers/distributors/customers yellow plastic liner. They are not approved for use by the FDA. ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Before opening your replacement device package, unplug your affected device and disconnect all accessories. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. Medical Device Recalls. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. How many Adult SMART pads cartridges will I receive? U.S. only: If you are looking for more information on how to use your new device and become familiar with it, you can visit www.philips.com/ds2-replacement for more information. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. As a result, testing and assessments have been carried out. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. Lift out the used SMART pads cartridge. Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models . If the problem occurs and you do not have a spare pads cartridge, attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive. When will a correction for this issue be ready? While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a different, silicone foam. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Smart PADS CARTRIDGE , (0-8 YE Philips, REF M5071A, Adult. The pads cartridge will be released. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. After five minutes, press the therapy button to initiate air flow. Should I store a spare pads cartridge with my HS1/OnSite/Home AED? For each rescue, a SMART Pads Cartridge replacement is required. Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II. Lift out the used SMART pads cartridge. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. It is not possible to know prior to patient use if a pad is affected because the pads are protected by a foil seal. Philips HS1 Adult SMART Pads Cartridge M5071A / 861291 They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. As a result, testing and assessments have been carried out. communication. AED Pads Medical Device Correction Notice | Philips Vendors Other Products. Philips had determined there is a need to emphasize the importance o. Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The gel may fold onto itself resulting in reduced surface We do not offer repair kits for sale, nor would we authorize third parties to do so. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS. As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1 AED. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). AED Recall - Were you aware? | Courtemanche & Associates Dear Customer, A problem has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. As part of our commitment to quality and patient safety, Philips is dedicated to removing product containing the affected sound abatement foam from the market. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. Lift out the used SMART pads cartridge. What happens if a pad with peeled gel is used on a patient? Part #: M5071A (34) Write a Review Your Price: $75.00 Front Add Ons Infant/Child Electrode Pads $115.00 Spare AED Battery $175.00 AED Check Tag $5.95 Adult TRAINING Cartridge $119.00 ARCH AED Medical Direction $149.99 Qty Add to Cart Add to Wish List Jump To: Overview Customer Reviews Overview While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a different, silicone foam. No matter the state of the pads, follow the voice prompts because the AED will walk you through the necessary actions. Instructions for Downloading Viewers and Players. I sent in my DreamStation CPAP device and received a DreamStation 2 CPAP Advanced and I would prefer to have my own device back. Philips Respironics did not have conclusive data indicating that exposure to the particulates or emitted chemicals would lead to cancer. What should customers or users do? Customers will be contacted directly BY THE PHILIPS DISTRIBUTOR THAT PROVIDED THE AED DEVICE. HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). If you have permanently taken your HS1/OnSite/Home AED out of service, please make a note of the Serial Number(s) of the HS1/OnSite/Home AED(s) that were taken out of service if available and contact Philips or your local Philips Representative. If you are a patient who has been affected by this recall, please do not try to remove the foam from your device. Since then, he has led the organization through the voluntary medical device recall of certain CPAP, BiPAP and Mechanical Ventilator devices. As soon as we receive the device, we replace the sound abatement foam and associated air pathway blower with brand new parts. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio.