RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Noise, Audible (3273)
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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: 05oct2020.
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Event Description
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The customer reported a ventilator with a noisy blower.The manufacturer's field service engineer confirmed the reported problem.This event was reported to have occurred during clinical use.There was no allegation of harm associated with this report.The manufacturer's field service engineer replaced the blower assembly to address and correct this reported event.
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Manufacturer Narrative
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G4: 02nov2020 b4: (b)(6) 2020 the determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred.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: 02nov2020 b4: (b)(6) 2020 h11: h6: patient code updated: the device was not being used for treatment when the reported event occurred.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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