The field service technician (fst) disassembled the unit, removed and replaced the control pcba (hl20 rpm) (material# 701007754, serial# (b)(4)) reassembled and tested per manufacture specifications.The unit passed all tests and calibrations and is now ready for clinical use.The defective control pcba (hl20 rpm) has been requested for return to germany to perform further investigation in our life cycle engineering (lce).A supplemental medwatch will be submitted after new information has been received.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
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The investigation was performed in the life cycle engineering in rastatt and the report (b)(4) was received on 2020-04-09.A pump control board (material number 70105.3021 and spare part number 70100.7754), hereinafter called the dut, was received for investigation and testing.The pump control board exchanges signals with the rest of the boards in the system and processes the information to, for example, display the speed value or trigger errors.The dut was visually inspected; no damaged or missing components were detected.During functional testing a group of different errors were triggered during start up and the device conducted startup routines repeatedly.The reported reboot cycle was not of a power supply, but of a component failure nature ; no disturbances were observed in the voltage supply.The most probable root cause is a defective microcontroller ic1 on the pump control board.Thus the reported failure could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary's trending program and additional investigations or corrections will be implemented in case of adverse trending.
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