RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that a 100a "data acquisition (da) printed circuit board assembly (pcba) analog to digital converter (adc) reference failed" error occurred.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that a 100a "da pcba adc reference failed" error occurred.The bme also stated that the power management (pm) pcba and da pcba were replaced, but the da pcba was fried.The bme attempted to put the old da pcba back in the device and stated that the chip was fried upon doing so.The remote service engineer (rse) created an onsite work order (wo) to have the device evaluated and repaired.
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Manufacturer Narrative
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H10: an authorized service provider (asp) was dispatched onsite, and upon arrival, the asp found that the biomedical engineer (bme) had removed the damaged parts.The asp then replaced the motor controller (mc) printed circuit board assembly (pcba), central processing unit (cpu) pcba, and power management (pm) pcba.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.If additional information is received, the complaint file will be reopened.
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