Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions),h10 additional contact information: contact person name:(b)(6) email: (b)(6) phone number: (b)(6) it was reported that during pm the cardiosave intra-aortic balloon pump (iabp) had a no external ecg/bp.There was no patient involvement, and no adverse event was reported.A getinge field service engineer evaluated the unit and found that device was not reading external ecg/bp gain readings.Replaced front end board.Nothing in logs.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing department received the following part associated with this complaint: pcb front end rohs.This part was received with a reported unit failure message of no external ecg/bp.Performed visual inspection of this part received and observed pins banded and one pin broken on j11 connector.Due to broken pin and banded pins, the fat dept, cannot investigated this part with cardiosave test fixture.This probably cause of no external ecg/bp.Retaining front end board in the fat dept, as per procedure(b)(6) rev aq.Due to damaged and banded pins this part is not going back to 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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