MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation & resolution and disposition device evaluation: the unit was received t the international service center for evaluation.The technician was unable to duplicate the reported low priority alarm, but the occurrence of e1104 (backup alarm failed) was confirmed in the diagnostic log.Resolution and disposition: cpu pcba will be replaced preventively.Arrival of components is awaited.Repair completion date is pending.Pt age: in her 60s.

Event Description

The international customer reported the v60 unit displayed occurrence of check vent low priority alarm occurred, so the unit was replaced.Unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

The reported complaint was not duplicated but the occurrence was identified in the diagnostic event log.Cpu board was replaced to prevent recurrence.Unit was checked overall, cleaned, run in tests and functionally tested.

Manufacturer Narrative

The cpu board was returned to the v60 vent manufacturing facility for evaluation.Visual inspection did not identify any signs of damage or contamination.The cpu board was installed in a test ventilator.The ventilator was powered only by ac without backup battery and power cycled every 30 seconds over one hour.No errors related to the reported backup alarm failed were generated.No failure was found.Therefore, the root cause for the backup alarm failed occurrence could not be identified.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6214376
• MDR Text Key: 63799301
• Report Number: 2031642-2016-03626
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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