During the laboratory analysis being performed by the manufacturer's product surveillance technician (pst) on 16apr2024, it was found that there was damage due to overheating of a component on the auxiliary (aux) printed circuit board assembly (pcba) and the single board computer (sbc) pcba.The power supply was replaced with a lab use only (luo) power supply and the issue remained.It was determined that the excessive heat damage to the component on the aux pcba caused the bpm to not power up and not operate to specification.The service repair technician (srt) replaced the sbc board and the aux board.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) screen was blank upon power up.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.The device was returned to the manufacturer for further evaluation where it was found that there were internal components that had evidence of heat damage.
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