MAQUET CARDIOPULMONARY AG

Description of Event or Problem

IT WAS REPORTED THAT WHILE THE HEART-LUNG-MACHINE HL 20 WAS IN STANDBY FOR BATTERY CHARGING, THE POWER SUPPLY BOARD INSIDE THE HL 20 BURNED. THIS OCCURRED PRIOR TO CLINICAL USE AND NOT IN THE OPERATION ROOM. (B)(4).

Additional Manufacturer Narrative

MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE RETURN OF THE DEFECTIVE HEART-LUNG-MACHINE. PICTURES OF THE UNIT HAVE BEEN RECEIVED AND REVIEWED. AT THIS TIME, THE HEART-LUNG-MACHINE IS STILL LOCATED IN (B)(6). UPON RECEIPT OF THE UNIT, THE (B)(4) FACILITY WILL CONDUCT AN INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.