RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Intermittent Continuity (1121); Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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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: 13sept2019.The manufacturer¿s international service technician confirmed the reported issue.The manufacturer¿s international service technician replaced the defective front bezel to address the reported problem.The unit successfully passed the required performance verification test.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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Event Description
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The customer reported nav-ring faulty and intermittent.The device was not in use at the time of the reported event; therefore, there was no patient involvement.
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Search Alerts/Recalls
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