RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
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 02/08/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint on the v60 device indicating that error codes 1113 "barometer calibration data error", 110f "o2 flow sensor calibration data error", 1107 " proximal pressure sensor calibration data error" occurred.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.
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Manufacturer Narrative
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Error 1006 "da pcba adc failed" also occurred.There was no patient involvement at the time the error codes were discovered as the device was not in use and was pulled from service.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse spoke with the biomedical engineer (bme) about the history of the device and inspected the device.The fse then let the device run and cycle normally and reviewed the information screen and event logs.The fse noticed that components were replaced recently prior his visit and discovered that the error codes in question were from august 2023.The fse was not able to recreate the error codes while testing and running the device.The error codes could not be duplicated.The fse confirmed that the device successfully passed performance verification and electrical safety testing and was returned to service.
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