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Anesthesia System Recalled For Failing To Switch On and Off Possibly Causing Severe Injury


The FLOW-i Anesthesia System, which administers anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as supporting patients with a limited ability to breathe, was voluntarily recalled. This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Maquet Critical Care AB and MAQUET Medical Systems USA issued an update regarding its voluntary worldwide field correction for its C20, C30 and C40 FLOW-i Anesthesia Systems. The February 20, 2012, recall was related to a software problem with the MAN/AUTO switch used for changing between manual and automatic ventilation modes.  The corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals.

 

In specific C20, C30 and C40 FLOW-i Anesthesia Systems, if the MAN/AUTO switch was not fully engaged in either an "ON" or "OFF position, but rather was placed in an "in-between position" for more than five seconds, a Technical Alarm TE 613 may have been generated. Activation of the Technical Alarm TE 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. To deactivate the Technical Alarm TE 613, the system must be restarted.

 

The FLOW-i Anesthesia System was distributed from May 9, 2010 through December 29, 2011. On February 20, 2012, the firm sent its customers an Urgent Device Field Correction notice. The firm informed their customers that a Maquet Service Representative will upgrade the software in their FLOW-i Anesthesia System to the current version and also provide them with the corresponding user manual. The firm added that the upgrade includes other minor improvements.

 

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