MAQUET/Datascope—CS100/CS100i, CS300, and System 98/98XT Intra-Aortic Balloon Pump Power Supplies: Fan May Fail, Potentially Causing System Shutdown
April 2, 2014 | Risk Management News
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In a March 21, 2014, Product Recall Urgent Medical Device Field Correction letter submitted by ECRI Institute member hospitals, MAQUET states that mechanical failure of the fan assembly associated with the power supply of the balloon pumps below may cause the power supply to overheat and the IABP to shut down without any visual or audible warning. MAQUET also states that a sudden interruption of IABP therapy for patients may result in unsafe hemodynamic instability because a sudden shutdown will prevent inflating or deflating of the balloon. The manufacturer has not confirmed the...