(b)(4).The complaint is confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed a short between capacitors c127 and c28 as well as overheating damage to the auxiliary pcba board.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.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 procedure, the blood parameter monitor (bpm) would not power on.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.
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