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 12/06/2023 |
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 after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared, and the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The investigation is ongoing.
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Manufacturer Narrative
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The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The asp engineer found that the da pcba was faulty and stated that the equipment department of the hospital replaced the da pcba to resolve the issue.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.
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