MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC 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 08/09/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit had an error: check vent, backup alarm failed.Based upon the information provided, the device was in clinical use providing therapy at the time of the event reported.No harm or injury has been indicated or alleged.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 the unit had an error check vent backup alarm failed.The customer verified there was an error code 1104 in the event log.The customer was unable to reproduce the error code.The rse provided the customer with the service manual rev n and recommended to repair cpu pcba.The rse instructed the customer to install software 3.00, reprogram serial #, power on hours and call back with the new cpu pcba part # and serial # for the software option codes.The customer stated he has all 6 option codes.The rse recommended for the customer to take a picture before repairing the unit.The customer is taking responsibility to correct/repair the device.The customer has been notified to contact philips if this does not address their device issue at which point a new service order will be created.No further information will be obtained as this concluded philips remote support to the customer for this event.

Manufacturer Narrative

The customer replaced the cpu 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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12422882
• MDR Text Key: 269828795
• Report Number: 2031642-2021-04815
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/07/2021
• Date Device Manufactured: 04/05/2013
• 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