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 04/03/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint from the customer reporting a proximal pressure sensor autozero error message occurred on the v60 ventilator.The device usage was not provided, therefore is unknown.There was no report of harm.There was no patient or user impact.The device did not meet specification for intended use and was removed from service.The biomedical engineer (bme) reported the diagnostic code 110a was confirmed in the device event log, indicating a proximal pressure sensor autozero error had occurred.A service proposal was provided to the customer which was declined.The service case notes were updated with customer canceled the repair service because the issue no longer occurs.No work was performed by philips service.No further details available.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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Manufacturer Narrative
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H10: g: phone: (b)(6).
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Search Alerts/Recalls
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