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 the customer stated that the iabp would not run on battery power.When the fse arrived on site the iabp was plugged in and the battery charging indicator was blinking, indicating that it was in charging mode.The battery charge on/off switch was in the "on" position.The iabp showed full battery charge on the display and continued to operate when it was unplugged.The fse replaced the batteries, checked for the charge indication, and that the iabp would run on batter power when unplugged.The fse returned the iabp back to the customer cleared for clinical use.
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