RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Crack (1135); Inaccurate Flow Rate (1249)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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: 09/10/2019.The manufacturer's field service engineer confirmed the reported nav-ring issue.The manufacturer¿s field service engineer (fse) replaced the defective front bezel to address the reported problem.The unit successfully passed the required performance verification test.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.If parts are returned, the complaint will be reopened.
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Event Description
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Nav-ring issue, cracked enclosure, and air flow accuracy failed.There was no patient involvement.
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Search Alerts/Recalls
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