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

Model Number DREAM STATION AUTO

Device Problems Nonstandard Device (1420); Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Philips cpap recall.Noticed black areas/specks in the cushion above the water area chamber.Fda safety report id # (b)(4).

• Brand Name: PHILIPS CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12852038
• MDR Text Key: 281158116
• Report Number: MW5105493
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAM STATION AUTO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2021
• Patient Sequence Number: 1
• Patient Sex: Male