RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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: 22sep2020.
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Event Description
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The customer reported electrical safety test failure.The unit was not in use, and there was no patient or user harm reported.
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Manufacturer Narrative
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The remote service engineer (rse) confirmed the failure.The customer removed the two screws holding the retention plate of the oxygen (o2) inlet at the back of the v60, then removed all ¿loctite¿ from the screws then removed ¿loctite¿ from inside the unit by moving the screws in and out repeatedly.The customer then cleaned off the screws and returned it to the v60 to hold the repair plate.The unit passed extended self-testing (est), and was returned to service.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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