RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the manufacturer's field service engineer (fse) on the v60, indicating that the device had burnt marks on pins.It was reported there was no patient involvement at the time the issue was discovered.The manufacturer's field service engineer (fse) was dispatched to the site for service and repair, while performing service, it was observed that the pins were damaged between the flow sensor assembly and the data acquisition (da) printed circuit board assembly (pcba).There was a short on the board, cable to the digital to analog converter (dac) board and motor controller (mc) board which caused burnt pins on the dac board.This caused a blank screen.
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Manufacturer Narrative
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H10: the manufacturer's field service engineer (fse) replaced the motor controller (mc) printed circuit board assembly (pcba), and the data acquisition (da) to mc pcba 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.Based on information provided and/or service performed it has been confirmed unit did not meet product specifications.The device was not being used for treatment when the reported event occurred.
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