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

Model Number DSX500H11

Patient Problem Atrial Fibrillation (1729)

Event Date 02/01/2022

Event Type  Injury  

Event Description

I purchased a philips cpap machine from cpap.Com to treat my sleep apnea a couple of years ago.Philips announced a recall of this device because of the possible health risk posed by the foam inside the machine.I registered my device as part of the recall program in 2021 and until now i still haven't received the replacement foam.I haven't used the machine since the recall was announced and now i have been diagnosed with atrial fibrillation and my cardiologist says it is most likely caused by my untreated sleep apnea.I need my cpap to be repaired as soon as possible so that i can start using it again.

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 18759149
• MDR Text Key: 336119557
• Report Number: MW5151820
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022478
• UDI-Public: 00606959022478
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500H11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic