MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAM STATION AUTO BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2022

Event Type  malfunction  

Event Description

I've became unsure about using my bipap.I noticed particles in my mask and symptoms of a cold that seem to happen every time i used it.Fda safety report id# (b)(4).

• Brand Name: DREAM STATION AUTO BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 15067399
• MDR Text Key: 296338187
• Report Number: MW5110993
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/17/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: Black Or African American