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 04/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: g1: phone: (b)(6).
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Event Description
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Philips received a complaint from the customer, reporting that the v60 ventilator had an autozero failure.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had an autozero failure.The customer reported that the alarm listed solenoids 1 and 4 were not detected and had buttons for solenoid 1 and 4 greyed out.The customer reported that the device had recently had a flow sensor assembly replaced.The rse advised the customer to check the pins on the solenoids and ensure that the pins were seated correctly with the data acquisition board.The rse recommended that the customer replace the solenoids and/or data acquisition board.The customer was provided with the part number for a replacement.Investigation ongoing.
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Manufacturer Narrative
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Insufficient information is available to determine the resolution of the event.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.
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