It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) had a blank screen and no power.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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The reported complaint was confirmed.Per the laboratory evaluation, a cracked battery was found that had leaked internal fluid.The battery leaking was confirmed to have reached the printed circuit board assembly (pcba).Battery acid has damaged the circuits and was present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the failure.The product has been moved to the service department for disposition, and will be scrapped.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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