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

Model Number UDSX500S11F

Device Problems Contamination (1120); Nonstandard Device (1420); Defective Device (2588)

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

Event Date 10/29/2023

Event Type  malfunction  

Event Description

I started using the prescribed philips respironics dreamstation auto cpap in (b)(6), which was recalled on 7/13/2021.I received the replacement "recertified device" (b)(6) 2023 and used it.This was a returned device of the recall that was supposedly reworked with the defective filter replaced with a new silicone one and therefore "recertified".On 4 or 5 instances, i noticed fine, black particulates on the mask, but since "recertified", assumed that the device was okay, cleared it out and continued to use.On 10/28/2023, tv's pbs did a story on the problems of philips' recall and the problems of their failed efforts, so i inspected my mask closely and found more tiny, black particles, photographing and collecting them.I called philips recall number (1-877-907-7508) and explained this to their (b)(6) (in usa), but we got cut off, so i called back and relayed my observations to their (b)(6) (in asia).She emailed me asking to see my photos (which i will send if needed), but told me that there was nothing that she could do to rectify my defective "recertified device".This is unacceptable performance by a us medical device manufacturer! my email is (b)(6).Reference report: #mw5147823.

Event Description

Additional information received for report mw5147824 on 01-03-2024 to add photograph.

• Brand Name: RESPIRONICS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18083563
• MDR Text Key: 328112816
• Report Number: MW5147824
• 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,Followup
• Report Date: 10/31/2023

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
• Device Model Number: UDSX500S11F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2024
• Patient Sequence Number: 1
• Treatment: 81MG ASPIRIN.; ATORVASTATIN.; CA.; MULTI-VITAMIN.
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White