The investigation by ge healthcare (gehc) has been completed.The ge mr system is not used to provide the ablation treatment, but rather as an imaging tool to verify that the medtronic catheter was previously positioned correctly during surgery and also to provide imaging during the procedure.During the course of the procedure, the mr system became unavailable due to a component failure.Clinical protocols exist that allow for safe abort of surgical procedures.A review of the system hardware and software logs was conducted.It was found that the mr system became unavailable due to a hardware failure of the scan room power supply (esrps).Prior to the failure, the mr system and esrps were fully operational, with no unusual errors reported in the system error logs.This defect appears to be a unique failure of this off-the-shelf component.The esrps was replaced and the ge mr system is operational.
|