Model Number V60 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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