RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint on the v60 ventilator indicating that there was a check vent proximal pressure failed error code.The device was reported to be in use at the time of the reported problem.No patient harm reported.The customer informed the remote service engineer (rse) that the issue occurred after 15 minutes in use on a patient.The rse recommended that the customer perform the following troubleshooting steps: verify the pin alignment between the solenoids and the data acquisition (da) printed circuit board assembly (pcba), replace the proximal autozero solenoids 3 and 4, and finally replace the da pcba.The rse provided the customer with the part information for the solenoids.This investigation is ongoing.
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Manufacturer Narrative
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H10: in a good faith effort (gfe) response from the customer received on 23oct2023, it was stated that the pin alignment was not checked for and the customer instead chose to go directly for a solenoid part replacement.The 3rd and 4th solenoids were ordered, received, and replaced at the customer site and the device was then run on a test lung for 24 hours with no alarm.The device was returned to use and returned to full functionality.The customer stated that they would try to mail the replaced solenoids for return in the week of 23oct2023.The device diagnostic report (drpt) was not available.The customer stated that the request for patient information was forwarded to respiratory department.Multiple good faith efforts (gfe) were attempted on 18oct2023, 24oct2023, and 14nov2023 to obtain the patient information from the time of the event.No further information was received from the customer.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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