Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall - Shuts Off Without Warning
MedSun: Newsletter #62, July 2011
FDA MedWatch Safety Alert
Defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events. Maquet Datascope Corporation notified customers by letter on March 17, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were advised that their Service Representative would arrange to replace the power supply on affected devices which would contain a new fan assembly.
FDA MedWatch Safety Alert. Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning. June 14, 2011.