RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Use of Device Problem (1670); Defective Component (2292)
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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: 06jan2021.
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Event Description
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The customer reported oxygen not available alarm when set above 50%.There was no patient involvement.The manufacturer's technical services (ts) confirmed the reported issue.The customer was advised to check the oxygen source and to follow the troubleshooting steps in the manual and that the issue may be a faulty flow sensor, oxygen valve, or (data acquisition) da pcb.The customer replaced the defective flow sensor to address the reported problem.The unit successfully passed the required performance verification test.
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Search Alerts/Recalls
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