MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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

Patient Problem Sleep Dysfunction (2517)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

I cant use it; can't sleep; this is a philips respironics device from 2009 and subject to the recall.I was not using it for many years, but started using it again in (b)(6) because i had an updated sleep study.(i am awaiting a luna bipap, still, after six months).But in early (b)(6), black particles came into the mask and on to my bed.I tried to air it out, but to no avail.The doctor who prescribed this originally will not provide me the name of the dealer to take the unit to, and philips has not asked for it back to repair it.(b)(4), distributor of the luna machine, just keeps sending me emails and voice mails that due to the recall, they are backordered.They told me that philips won't replace my machine for six months to a year.So, i am not sleeping well at all.I really think fda botched this recall by not allowing patients to take this to a service center to be fixed.I think more people will die or get injuries from not being able to use their cpaps/bipaps than from these particles.I would appreciate a phone call to discuss with one of your people (b)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14407988
• MDR Text Key: 291855611
• Report Number: MW5109695
• 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: 05/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: I DONT WISH TO PROVIDE
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White