The production device history record (dhr) for this intra-aortic balloon pump (iabp) is 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 field service engineer (fse) was dispatched and reported that the customer stated that they smelled smoke coming from the iabp.After inspecting the iabp, the fse could not smell smoke and no faults were recorded in the fault logs.The iabp passed all functional and safety tests per factory specifications and was returned to the customer, cleared for clinical use.
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