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

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

I was not notified that my philips respironics cpap "dreamstation" was recalled until: (b)(6) 2021, when i received the recall notice in the mail from philips, why did it take so long? weren't patients notified back in (b)(6)? - i still have not heard from either my medical equipment provider, nor my sleep doctor; why? yes, my machine has the problem of the foam breaking into particles, but, i did not realize that it was the machine malfunctioning.At first, i thought it might be a bug, floating in my humidifier tank, because it was black.Then i guessed it was just dust from the filter.I did not know, because i had not been advised.Neither by philips, nor by my medical equipment provider, nor by my sleep doctor.Hence, philips saying it has "a low complaint rate".How were we, the patients, supposed to know to watch for this? so, i kept using my cpap machine.I noticed it: months ago.Even long before that, i noticed that my cpap machine was getting louder, and louder.I used my machine a total of 19 months (re.Off-gassing, etc.) - no, i never used any ozone cleaner.I just washed everything by hand, as instructed by my medical equipment providers - yes, i have registered my dreamstation cpap machine with philips, who confirmed: it is an affected device that is recalled.I haven't had any tests yet, as my sleep doctor still hasn't contacted me to notify me of the recall of my philips dreamstation cpap machine.Shouldn't doctors have notified their patients: months ago? neither have i been contacted by my medical equipment provider either.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12506621
• MDR Text Key: 272708067
• Report Number: MW5104086
• Device Sequence Number: 1
• Product Code: BZD
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other