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

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Cough (4457); Respiratory Insufficiency (4462)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

I use the philips asv machine.Starting in (b)(6) of 2022, i developed a cough and headache and mild breathing problems.The cough has continued until now - i have been tested for covid and flu and did not have either.I had a chest xray in (b)(6) and all looked ok in the lungs.But i still have the cough and now have to use an inhaler to help with the breathing issues.My name is (b)(6).Fda safety report id# (b)(4).

• Brand Name: ASV BIPAP MACHINE DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13783139
• MDR Text Key: 287433039
• Report Number: MW5108184
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White