RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
No Device Output (1435)
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Patient Problem
No Patient Involvement (2645)
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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 this report: 22 may 2020.
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Event Description
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The customer reported a ventilator with no power response.There was no patient involvement.
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Manufacturer Narrative
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G4: 12nov2020.B4: 13nov2020.The manufacturer's field service engineer replaced the power adapter to address and correct the power supply failure.There is no allegation of a battery failure found on the case record.The battery was replaced preventatively.Multiple good faith efforts were made to obtain additional information of regarding the device and the malfunction with no response from the reporter.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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Manufacturer Narrative
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G4: 10aug2020.B4: 16sep2020.The manufacturer's field service engineer confirmed the reported problem.The manufacturer's field service engineer replaced the battery and power adapter to address and correct the reported event.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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