MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AUTO CPAP

Device Problems Material Erosion (1214); Nonstandard Device (1420); Particulates (1451); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Philips recalled their cpap machine for problems with the internal filters and i registered for a replacement of device serial no: (b)(6), model: auto cpap.Although i have spent much time on the phone, on their portal, etc.Nothing happens and they keep redesigning their website to direct down another hole leading nowhere or giving you a new phone number to call.I don't trust anything they say any more.(b)(4)- registration no.To replace cpap june 2021 the recall was announced.On 4/14/2022 - called 1-877-907-7508 & talked to (b)(4) to find out why i couldn't verify dme(durable medical equipment) registration on philips recall updates (expertinquiry.Com) it turned out that my name was spelled wrong (b)(6) instead of (b)(6).She will correct, but it will take up to 48 hours to fix.In the meantime, she suggested i call my dme ((b)(6)) and see if they have received the replacement.12/5/2022 - (b)(6) called from (b)(6) medical (b)(6) - said m/c could not replace since my machine isn't 5 years old (purchased in aug 2019).She checked to see if i could purchase one and (b)(6) medical isn't taking any out of pocket purchases.The recall is for the foam inside the machine.I am not using ultraviolet or other cleaning products, so i may be okay (that is my thinking) urgent: medical device recall philips respironics cpap and bi-level pap devices sound abatement foam susceptibility to degradation and volatile organic compound emission to the patients who use philips sleep & respiratory care devices: philips respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (pe-pur) sound abatement foam used in philips continuous and noncontinuous ventilators: pe-pur foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user, and the pe-pur foam may off-gas certain chemicals.The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see fda safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device's useful life.These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.Philips respironics has received complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).The potential risks of particulate exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.G.Kidneys and liver) and toxic carcinogenic affects.The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects 12/5/2022 - i checked philips.Com/srcupdates to see if there could be a problem that sleep technology was still listed as my dme and will have to call to get that checked as i could find no spot on the website.Website continues to say that it may take to the end of the year or later to replace.Hours are 8 to 5 est 877-907-7508, 12/7/2022 - called 877-907-7508 and talked to (b)(4) who verified all my information (name, address, phone number, email) but couldn't tell what my dme of record was.She kept saying that she couldn't say "when" but that sometime maybe toward the end of the month, but maybe not, "they" (which she said was philips respironics) would send a replacement machine to my address or my dme would contact me.I asked her who "they" showed my dmeto be and she couldn't.She couldn't tell me which method of delivery would happen.On 2/28/2023 - went to patient portal philips recall updates (expertinquiry.Com) they say 90% of recalls have been replaced - the sites.

Event Description

Philips recalled their cpap machine for problems with the internal filters and i registered for a replacement of device serial no: (b)(6), model: auto cpap.Although i have spent much time on the phone, on their portal, etc.Nothing happens and they keep redesigning their website to direct down another hole leading nowhere or giving you a new phone number to call.I don't trust anything they say any more.(b)(4)- registration no.To replace cpap june 2021 the recall was announced.On 4/14/2022 - called 1-877-907-7508 & talked to (b)(4) to find out why i couldn't verify dme(durable medical equipment) registration on philips recall updates (expertinquiry.Com) it turned out that my name was spelled wrong (b)(6) instead of (b)(6).She will correct, but it will take up to 48 hours to fix.In the meantime, she suggested i call my dme ((b)(6)) and see if they have received the replacement.12/5/2022 - (b)(6) called from (b)(6) medical (b)(6) - said m/c could not replace since my machine isn't 5 years old (purchased in aug 2019).She checked to see if i could purchase one and (b)(6) medical isn't taking any out of pocket purchases.The recall is for the foam inside the machine.I am not using ultraviolet or other cleaning products, so i may be okay (that is my thinking) urgent: medical device recall philips respironics cpap and bi-level pap devices sound abatement foam susceptibility to degradation and volatile organic compound emission to the patients who use philips sleep & respiratory care devices: philips respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (pe-pur) sound abatement foam used in philips continuous and noncontinuous ventilators: pe-pur foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user, and the pe-pur foam may off-gas certain chemicals.The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see fda safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device's useful life.These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.Philips respironics has received complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).The potential risks of particulate exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.G.Kidneys and liver) and toxic carcinogenic affects.The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects 12/5/2022 - i checked philips.Com/srcupdates to see if there could be a problem that sleep technology was still listed as my dme and will have to call to get that checked as i could find no spot on the website.Website continues to say that it may take to the end of the year or later to replace.Hours are 8 to 5 est 877-907-7508, 12/7/2022 - called 877-907-7508 and talked to (b)(4) who verified all my information (name, address, phone number, email) but couldn't tell what my dme of record was.She kept saying that she couldn't say "when" but that sometime maybe toward the end of the month, but maybe not, "they" (which she said was philips respironics) would send a replacement machine to my address or my dme would contact me.I asked her who "they" showed my dmeto be and she couldn't.She couldn't tell me which method of delivery would happen.On 2/28/2023 - went to patient portal philips recall updates (expertinquiry.Com) they say 90% of recalls have been replaced - the sites.

• Brand Name: PHILIPS CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17248214
• MDR Text Key: 318366514
• Report Number: MW5119061
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AUTO CPAP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White