It was reported that during set-up of the device for a cardiopulmonary bypass procedure, after blood parameter monitor (bpm) was on a short time the screen faded out.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.
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The reported complaint was confirmed.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 is present on the circuit board (acid is conductive and can create short circuit conditions) and is considered to have caused the failure.Product has been moved to 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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