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

Model Number DSXHCP

Patient Problems Pneumonia (2011); Viral Infection (2248); Respiratory Failure (2484)

Event Type  Death  

Event Description

My mother used her philips dreamstation every night.She was aware of a recall, inquired about it and was told her machine was ok to use.She went to sleep on the evening of (b)(6) 2022, wearing her philips cpap(continuous postive airway pressure) and never woke up.Her official cause of death was respiratory failure from covid pneumonia, but no autopsy was performed.We are now unsure if her respiratory failure was due to covid or the cpap medical device.Refer to add'l documents in i2k.

• Brand Name: PHILIPS RESPIRONICS DREAM STATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18676009
• MDR Text Key: 335068553
• Report Number: MW5151223
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: (01)00606959022652
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: DSXHCP
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death