RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ |
Device Problems
Device Alarm System (1012); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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It was reported by a hospital medical engineer (me) that the unit was in stand-by mode and a noise occurred in the oxygen piping portion at backside of the unit.The unit was used only at night time and no alarm sounded and no error message appeared.The ventilator was on a patient at the time of the issue however no patient harm or delay to therapy was reported.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(6).
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Manufacturer Narrative
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The unit was checked in the hospital's me room being ceased to operate and oxygen piping was attached then our sales rep confirmed sound of oxygen leaking.The field service engineer (fse) confirmed the reported issue.The fse replaced the data acquisition board, and the issue was resolved.The unit was checked overall, cleaned, run-in and functionally tested.
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Manufacturer Narrative
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The gas delivery system was returned for failure investigation.No anomalies were noted during visual inspection.Failure investigation could not replicate the reported problem, no fault was found.The test ventilator executes standby mode normally and no abnormal noises occurred.The root cause for the reported complaint was not determined.
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Search Alerts/Recalls
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