RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
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 02/14/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the customer on the v60 indicating that the error, "machine and proximal pressure sensors failed", had occurred.It was reported there was no patient involvement at the time the issue was discovered.Onsite service is pending.Investigation is ongoing.
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Manufacturer Narrative
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H10: a field service engineer (fse) went onsite and replaced the motor controller (mc) printed circuit board assembly (pcba), central processing unit (cpu) printed circuit board assembly (pcba), and data acquisition (da) to mc cable with all performance tests passing to resolve the issue.The fse replaced the mc pcba, cpu pcba, and da to mc cable 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.
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Search Alerts/Recalls
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