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It was reported during use on a patient the charge nurse, called from the ccu regarding, the cardiosave intra-aortic balloon pump (iabp) she stated that the pump smelled like it was burning.She stated the fan on the pump was noisy.The primary nurse was not able to come to the phone, but she understood it did not shut down or go into standby.The staff successfully transferred the patient onto another pump and the patient was stable.
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Updated fields: (type of investigation, investigation findings, component codes and investigation conclusions).Corrected field: (initial reporter).Additional information: contact person phone number: (b)(6).A getinge field service engineer (fse) had evaluated the unit and noticed the multiple 135 and 118 fault codes in logs and broken fiber optic connector on the unit.Than the fse had replaced the power management board and fiber optic connector.Fse had also noticed that there leads to the blow of the cpu chip on executive processor board and black ash was present on front end board from blown chips, replaced both the boards.Than the fse had re-uploaded b.17 software , calibrated 30 psi and helium tank transducers and tested.The unit had passed all functional and safety test per factory specifications the unit was returned to the customer and cleared for clinical use.There was no involvement of the patient.The failure analysis and testing department received the following parts associated with this complaint: power management board, exec.Processor board, front end board.These parts were received with a reported unit failure message of burning smell, error code 139 & 118 in fault logs, blown cpu chip on exec.Processor board and blown chip on front end board.Performed visual inspection of these parts received and observed all received boards were not in good condition.During inspection of power management board, the fat dept., found out the q27 chip was not properly secured (soldering) to the board.Also, during inspection of exec.Processor board and front-end board, the fat dept.Observed the exec.Processor board cpu chip was burnt and front-end board chip was blown.Please see attached pictures.The failure analysis and testing department verified the failure message of power management board, exec.Processor board and front -end board.Due to these damaged on all boards the fat dept.Cannot be further investigated for all parts.Retaining all parts in the fat dept., as per procedure 0002-07-d008 rev ap.Due to the old revision for power management board cannot be send back to the supplier for further investigation.Due to the damaged on exec.Processor board and front- end board the fat cannot be send back both boards to the supplier for further investigation.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
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