RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Loss of Power (1475); Vibration (1674)
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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) 2018.Date of report: 13sep2019.The pse evaluated the device and confirmed the reported issue.The pse found that the device would need a new power switch overlay.The pse replaced the power switch overlay to resolve the reported issue.The pse also replaced as part pm the unit's oxygen inlet filter, air inlet filter and cooling fan filter.The device passed all testing.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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Event Description
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During periodic maintenance (pm), the manufacturer's product support engineer (pse) reported the power led turns off by vibration.There was no patient involvement.
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Search Alerts/Recalls
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