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 Problem
Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Reporting institution phone number - (b)(6).Reporter phone number - (b)(6).
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Event Description
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It was reported to philips by a customer was setting the device just before use on a patient, "oxygen device failed" occurred.Based upon the information provided, the device was being set up for use at the time of the event reported.No harm or injury has been indicated or alleged.When the hospital aide was setting the device just before use on a patient, "oxygen device failed" occurred.The alarm was not resolved at that time.However, the phenomenon was no longer duplicated when the device was started up and checked the next morning.Occurrence record of diagnostic code 120a was confirmed in the event log.It seems either the data acquisition board is faulty or the oxygen supply pressure on the medical institution side was too high.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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The issue was not duplicated.No parts replaced.The customer declined further repair and the device was returned as is.
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Search Alerts/Recalls
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