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 10/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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Philips received a complaint by the customer on the v60, indicating that while performing preventative maintenance, it was observed that event log revealed an error code "machine and proximal pressure sensors failed" (diagnostic code 1007) that had occurred.It was reported there was no patient involvement at the time the issue was discovered.The manufacturer's product support engineer (pse) evaluated the device and confirmed that the data acquisition board will need to be replaced.The pse replaced the data acquisition board to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Based on information provided and/or service performed it has been confirmed unit did not meet product specifications.It was determined that the data acquisition board was the cause of the reported issue.
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