MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS RP-PCBA., POWER MANGEMENT, V60 (FCO); VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/15/2021

Event Type  malfunction  

Event Description

V60 ventilator stopped abruptly after change of power management board.

• Brand Name: PHILIPS RP-PCBA., POWER MANGEMENT, V60 (FCO)
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 11482470
• MDR Text Key: 240127868
• Report Number: MW5099980
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• 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