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

Model Number DSX500T11C

Device Problems Material Disintegration (1177); Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problem Headache (1880)

Event Date 08/02/2021

Event Type  Injury  

Event Description

I use a philips cpap machine, model #dsx500t11c.I wake up in the middle of the night with a headache several times a month.This has only happened in recent months (25 years using cpap machines).I see that this and many other philips machines have been recalled (i checked serial #, mine has).I am concerned that the headaches stem from the toxic and potentially carcinogenic particles from the disintegrating foam that led to the recall.Nobody notified me of the recall: not philips, not my ent, not the (b)(6), not the medical equipment supplier (b)(4).This is outrageous when there is a potentially deadly problem with the machines.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12377361
• MDR Text Key: 268940776
• Report Number: MW5103541
• 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: 08/24/2021

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: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 102