The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) evaluated the iabp and was only able to recreate the reported complaint one time.It was determined that this was due to a faulty ecg trunk cable.However, the faulty cable was discarded.The stm fully tested the unit, and the iabp passed all functional and safety tests.The iabp was returned to the customer and cleared for clinical use.In addition, the stm found that one of the customer's ecg cables was found to have wet cleaning solution inside the ecg trunk cable to the lead wire connector.The customer was advised to alter their cleaning procedure as this could be a possible cause of the issue.The hospital biomed dept.Will continue to monitor the situation and report any additional issues.
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It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) had an ecg monitor issue.The customer was unable to acquire an ecg signal on their iabp unit.When the patient was disconnected from a transport monitor in the or and connected to the iabp, there was no ecg signal displayed on the iabp.The customer switched ecg cables and ecg electrodes several times without correcting the issue.No adverse event was reported.
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