Model Number 0998-00-0800-53 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a ecg port that did not hold the cable.There was no harm or injury to the patient and no adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the front end board then exorcised the iabp unit to no fail.A full calibration and functional check has been performed per the factory calibration procedures.The unit passed all test and calibrations and is now ready for clinical use.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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The fse was able to duplicate the reported malfunction during repair.The front end board that was replaced was returned to maquet national repair center (nrc) for evaluation.The nrc received the pcba,front end and installed part into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.The nrc verified the failure of a bad ecg connection.The ecg cable would not plug into the connector.The board failed testing.Retaining the board in the nrc per procedure.
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Event Description
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It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a ecg port that did not hold the cable.There was no patient involved.
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Search Alerts/Recalls
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