RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Grounding Malfunction (1271); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)
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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) 2020.Date of report: 21may2020.
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Event Description
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The customer reported higher blower temperature.There was patient involvement, but no one was harmed.The manufacturer¿s field service engineer (fse) could not duplicate the reported higher blower temperature issue, but verified the error of high blower temperature in the history.The fse ran the unit for half hour in normal mode, and no problem was found.All connections and tubing were secure.The fse replaced the blower assembly, and the motor controller as a preventative measure to address the reported problem.During failure investigation, the ground resistance test failed, so the power cord was replaced.The unit passed the required test of the performance verification successfully.
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Manufacturer Narrative
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G4: 09oct2020.B4: 13oct2020.The blower motor assembly was received for evaluation.Visual inspection of the blower assembly revealed no anomalies.A failure investigation (fi) technician installed blower motor into a fi ventilator to duplicate the reported issue.The fi ventilator was booted up unit in normal operation mode and checked for alarms and errors.The returned blower motor passed all testing, and the reported complaint was not verified and could not be confirmed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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