MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC BIPAP MACHINE; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Power Problem (3010); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Discomfort (2330)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

A covid-19 positive critically ill pt was on a phillips v60 bipap machine that high priority alarm triggered, with the following alarms showing "check vent: ventilator restarted, check vent backup alarm failed, check vent aux supply failed, check 35v supply failed, low inspiratory pressure, oxygen not available." the pt was removed from the machine, supplemental oxygen used until pt was emergently intubated a few minutes later.The failure is from a power management (pcba) board failure in the machine and the unit involved is part of a philips urgent medical device correction alert (02/2020 and 08/2020).These unit and 12 others (13 total) have been taken out of service until philips can replace the pcba's.Philips was contacted on 02/10/2020 to the expedite replacement.

• Brand Name: BIPAP MACHINE
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 11337596
• MDR Text Key: 232429356
• Report Number: MW5099425
• Device Sequence Number: 1
• Product Code: MNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/12/2021
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR