Health Canada — Medical Devices · Canada · 2015-02-16 · Type III
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Reported risk: Since the commencement of commercialization of the CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps (JABP) in December 2011, Maquet has received thirteen (13) power supply complaints that were determined to be related to suboptimal thermal management. It is important to note that none of the thirteen complaints identified any adverse patient events. Suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the CARDIOSAVE Hybrid JSBP console, and the inability to charge the batteries. Failure to provide the correct output voltage to the console will result in the unit not functioning from AC power, even when plugged into an active electrical outlet. Should a power supply malfunction occur, an on screen message will alert the healthcare provider that the CARDIOSAVE Hybrid JABP unit is operating on battery power.
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