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: 28sep2020 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 that the ventilator had a noise occur from inside the device.There was no patient involvement.The manufacturer¿s international service technician inspected the device and could not duplicate the reported issue.
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Manufacturer Narrative
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G4: 28sep2020.B4: 30sep2020.The reported issue was not duplicated.There was no noise confirmed.No parts need replaced.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.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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