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

Model Number DSX500T11W

Device Problems Degraded (1153); Leak/Splash (1354); Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problem Headache (1880)

Event Type  Injury  

Event Description

I have a philips dreamstation cpap that has been recalled due to breakdown of the black foam, and off-gassing of chemical games.I registered for the recall with philips, but haven't heard back.I purchased in-line filters that i have been changing.The filters are turning gray.I also have been experiencing headaches quite regularly in the temple area, which i have not experienced before.I plan on calling philips later today, during business hours, but i doubt that i will reach a representative.I'm very concerned about any health issues from continuous use of this cpap machine, but i need to sleep with a cpap due to my sleep apnea.Insurance will only pay for a new cpap every 5 years, and i got my philips dreamstation a little less than 3 years ago.Thank you for any help with getting philips to replace the affected units in a more timely manner.Sincerely, (b)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12934680
• MDR Text Key: 281876005
• Report Number: MW5105816
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11W
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Patient Sequence Number: 1
• Treatment: LOSARTAN ; PHILIPS CPAP ; POTASSIUM
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White