RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Electrical /Electronic Property Problem (1198)
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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) 2021.Date of report: 10feb2021.
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Event Description
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The customer reported a ventilator experienced a 35 volt failure during preventative maintenance (pm).The device was evaluated by the customer and philips remote service engineer (rse).The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The customer replaced the power management board to address the issue.Following the replacement of the part, the unit was functionally tested and successfully passed testing.The unit was returned to service.No other anomalies were observed.
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