RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint from the customer reporting a sensor alarm issue on v60 ventilator, which was later identified as a proximal pressure sensor autozero failed message.The device usage at time of the event is unknown.There was no report of harm, nor patient or user impact.The device did not meet specification for intended use and was removed from service.A philips authorized service provider (asp) evaluated the device and confirmed diagnostic code 110b in the device event log verifying the proximal pressure sensor autozero failed occurrence.The asp replaced gas delivery subsystem (gds) as per service manual.The device was operational and returned to service after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
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