RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The v60 reports problems with the o2 delivery.
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Manufacturer Narrative
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Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.Codes to use: no findings available/conclusion not yet available.
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Manufacturer Narrative
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H11 b5: philips received a complaint by the customer on the v60 indicating that there were o2 delivery problems, and a "o2 device failed" error code was displayed.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped out for another ventilator, but therapy was not interrupted or delayed.H10: after analyzing the event log and running performance verification tests, the customer replaced the oxygen solenoid valve, and the reported issue was resolved.The device passed required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.
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Search Alerts/Recalls
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