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Datascope Balloon Pump Training Courses11/14/2022 ![]() A similar software upgrade was released for the CS300 and CS100/CS100i in 2017. Theory training videos available to watch on the VLE and on. Maquet/Datascope is currently developing a Cardiosave battery maintenance software upgrade. There is an annual clinical currency required of Sydney HEMS consultants. The FDA continues to work with the manufacturer to examine and address the root cause of these IABP devices shutting down while running on battery power. Additionally, a reference guide specific to each IABP based on the Operating Instructions Manual(s) is now provided with each device. As part of the recall, Maquet/Datascope is contacting each customer to schedule a training visit to review updated battery instructions, use, care and maintenance. In July 2019, the FDA issued a notification about a Class I recall for all Maquet/Datascope Intra-Aortic Balloon Pumps (IABPs) due to the potential risk of battery failure. ![]() ![]() Although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically-ill patients in healthcare facilities, including during transport, and any interruption in treatment can result in serious patient harm or death. 1, 2018, the FDA has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury. ![]() Previously, the FDA informed healthcare providers in a letter about reports of Maquet/Datascope IABP devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. ![]()
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