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

Model Number DREAMSTATION REV00

Device Problems Material Discolored (1170); Material Fragmentation (1261)

Patient Problem Unspecified Infection (1930)

Event Date 12/20/2021

Event Type  Injury  

Event Description

I have a philips dreamstation cpap machine - built on 2017-03-13 - which is part of the recall and it has yet to be replaced.I've recently noticed pieces of what appear to be foam floating in my humidifier tank and discoloration (pink/gray residue) as well along with a frequent increase in sinusitis.I use distilled water 100% of the time so there's no reason for any sort of discoloration or material to show up in my tank.My most recent bout of sinusitis seems to coincide with times i notice material floating in the tank, e.G.On (b)(6) 2021.Philips has not sent any notification that my machine will be repaired or replaced any time soon.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13169335
• MDR Text Key: 283328477
• Report Number: MW5106460
• 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: 12/31/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION REV00
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP ; FINASTERIDE 1.25 MG/DAY; MAGNESIUM; VITAMIN B12; VITAMIN D 2000 IU; WELBUTRIN 100 MG / DAY
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White