RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Failure to Power Up (1476)
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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: 19oct2020.
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Event Description
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The customer reported that the unit won't power on.The customer contacted product support and requested for service repair.The customer reported that the unit was in use on a patient, but there was no patient harm reported.
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Manufacturer Narrative
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G4:18jan2021.B4:19jan2021.The field service engineer replaced the power management, battery and the blower to address the reported issue.The battery date code indicates that the battery is over 5 years old lot m50361-b0 2012-09.Per the v60/v60 plus ventilator service manual, the battery is to be replaced every five years as per periodic maintenance procedures.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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G4:18jan2021.B4:21jan2021.The field service engineer reported that the blower was replaced because there's no air coming out and the power management board was replaced due voltage error.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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Failure analysis on the returned motor controller (mc) board shows that the mc board passed testing and operates normally.No problem found with the motor controller (mc) board.
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Search Alerts/Recalls
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