RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Loose or Intermittent Connection (1371); Battery Problem (2885)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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: 20may2020.
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Event Description
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The customer reported they needed to replace a battery.The field service engineer (fse) noted during his preventive maintenance an aged battery.He also encountered a nav-ring inop and power cord with intermittent connection.The (fse) replaced the aged battery.He also replaced the front bezel to fix the nav-ring issue.Finally, the power cord was replaced to fix the intermittent connection.The unit passes all testing and the unit has returned to service.The unit was not in use, and there was no patient harm.
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Manufacturer Narrative
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G4: 21sep2020.B4: 29sep2020.The power cord was returned to manufacturer to failure investigation (fi) for analysis.The reported problem could not be replicated.No fault was found with the returned power cord.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is no relationship of the device to the reported problem.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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