MAUDE Adverse Event Report: RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury were reported.

Event Description

It was reported to philips by a customer that the unit's check vent primary alarm failed.Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury were reported.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device and diagnostic report, the customer stated that when powered on the unit gives an error message primary speaker failure.The customer found error motor controller speaker failure and error primary speaker failure in the error in log report.The rse verified in service log motor controller speaker failure & pm speaker passed and suspects the mc speaker is bad or possibly mc board and cpu.The rse recommended replacing the mc board, cpu and speaker assembly to the customer.It is unknown if any parts or repair has been conducted in relation to the alleged complaint.Attempts to obtain further information are currently pending.

Manufacturer Narrative

The service engineer replaced the cpu pcba and speaker assembly to resolve the reported issue.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12491118
• MDR Text Key: 272123620
• Report Number: 2031642-2021-04973
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: BG30400652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

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
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 11/01/2021
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1