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

Patient Problems Sneezing (2251); Unspecified Respiratory Problem (4464)

Event Date 02/16/2024

Event Type  Injury  

Event Description

I have a philips respironics cpap, as does my wife.We presently use cpaps that were replacements for earlier models that were recalled.We are experiencing continuous allergy like symptoms (sneezing, nasal congestion, etc.).We heard a recent interview on national public radio indicating that cpap machines sent as replacements due to the recall are continuing to have foam related problems and that philips is now going out of the cpap business.Please let us know what information the fda has on this topic and any recommendations regarding continued use of the replacement cpaps we received pursuant to the recall.Please don't refer me to philips.I no longer trust them.Thanks for your help.(b)(6).Reference reports: mw5152032, mw5152033, mw5152034.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18796810
• MDR Text Key: 336457460
• Report Number: MW5152031
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959063471
• UDI-Public: (01)00606959063471
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2019
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL.; ELIQUIS.; LOSARTAN.; MELOXICAM.; MULTIVITAMIN.
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White