MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS V 60 BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  Injury  

Event Description

The machine was plugged in on stand-by in patient room with the patient.The plug at the outlet sparked and had flames.Therapy dates: (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: PHILIPS V 60 BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14495677
• MDR Text Key: 292592049
• Report Number: MW5109907
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening