The customer reported that the patient's freedom driver exhibited an irreversible fault alarm while switching onboard batteries.The patient was subsequently switched to the backup freedom driver without adverse impact.Although the freedom driver exhibited an irreversible fault alarm, the driver continued to function as intended.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
|