RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Device Displays Incorrect Message (2591)
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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: 13oct2020.
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Event Description
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The customer reported getting an error 35v alarm on the main screen when in use.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.The manufacturer's technical services (ts) confirmed the reported issue.Advised caller per service manual revision k, of the suspect the (motor controller) mc pcb.The customer replaced the defective mc board to address the reported problem.The unit successfully passed the required performance verification test.
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