RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2020, date of report: (b)(6)2020.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Event Description
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It was reported the watchdog test failed.There was no patient involvement.The manufacturer's international service technician ordered a flow sensor assembly to replacement.
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Manufacturer Narrative
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G4: 06oct2020.B4: 07oct2020.The unit was in routine testing when the error appeared.As this testing is done prior to clinical application, there is no potential for patient harm and as such is not reportable.The international service technician replaced the flow sensor assembly and the issue was resolved.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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