(b)(4).The reported issue was verified by the field service representative (fsr) on site.He troubleshoot the compressor using field service handbook and measured voltages on compressor delay printed circuit board (pcb).The device had a line voltage at p-66 which was not expected.As per fsr, troubleshooting led to bad compressor.The device was not returned to the manufacturer as the customer has taken the unit out of service.The customer scrapped the device.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 use of the device for a cardiopulmonary bypass (cpb) procedure, the heater cooler (tcm ii) was recycling through out the procedure and intermittently resetting.The unit was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review on 06-feb-2017: as per certified clinical perfusionist (ccp), the tcm ii was re-set multiple times during the procedure.Re-set means the unit goes to standby (like it does on initial boot-up) which stops all pumps and heater functions.After the re-set was completed, the user can choose warming or cooling options.This re-setting, according to ccp, happened at least 3 times during the procedure.Once after initial priming of the tcm ii during preparation of the cpb circuit.Once just prior to the start of cpb, when the tcmii was being set and prepared for the start of cpb.Once during cpb, when rewarming of the water (to rewarm the patient) was initiated.As rewarming requires a consistent and steady rise in the water temperature, the tcm ii was changed out during this third re-set in order to prevent the potential for prolonged rewarming of the patient.The change out did not delay the procedure and the patient remained stable.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.
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