Reportedly, post repair, the device turns on, does the countdown to shut down and shuts off.Also, when it is plugged in the battery indicator does not come on.There was no patient involvement.No additional information is available.
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The complaint device was returned for evaluation.Incoming visual inspection found no anomalies.Technical visual inspection found no anomalies.Device evaluation found a mechanical failure in the motor.The epump motor was replaced with a new oem part.The software was set to 4.009.The device was calibrated.The case was checked for damage.The circuit boards were inspected.The alarm, battery, display, keypad, patient side occlusion, rate accuracy, self test/power, upstream occlusion and final visual inspection were all tested and passed.The root cause for the confirmed reported event was determined to be the failed motor due to aging.This type of event will continue to be monitored.
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