Flow-i Anesthesia System Recall Issued Due to Software Error
Problems that led to a voluntary field correction for an advanced anesthesia system could pose a serious risk of injury or death for patients, leading the FDA to classify the action as a Class I recall.
Following a Flow-i Anesthesia System recall issued earlier this year, Maquet Critical Care AB and MAQUET Medical Systems USA issued an update on July 6, indicating that the FDA considers the action a Class I recall, which is reserved for medical device recalls where the agency believes that continued use of the product poses a substantial risk.
Flow-i Anesthesia Systems distributed between May 2010 and December 2011 were subject to a voluntary field correction in February 2012, related to a software problem with the MAN/AUTO switch used for changing between manual and automatic ventilation modes.
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Correcting the problem involves upgrading the affected systems’ software and providing new corresponding user’s manuals. The action impacted Flow-I systems with model number C30 sold in the United States and model number C20, C30 and C40 sold worldwide.
The problem arises when the MAN/AUTO switch is not fully engaged in either an “ON” or “OFF position, and placed in an “in- between position” for more than five seconds. This sets off an alarm that causes the system to remain in the original mode selected and does not switch the ventilation mode. To deactivate the alarm the system must be restarted.
FLOW-i enables clinicians to continuously adapt and improve anesthesia care to match the situation at hand while maintaining stable respiratory conditions. FLOW-i can be used across the widest range of patient groups, including those with acute respiratory demands and pediatric patients. FLOW-i is manufactured by MAQUET Critical Care AB and distributed in the US by MAQUET Medical Systems USA.
MAQUET advises customers to contact their local technical support department for additional information regarding the recall. U.S. Technical Support can be reached, Monday through Friday, from 8:00 a.m. to 7:00 p.m., Eastern Standard Time (EST), toll-free, at 1.888.627.8383; press option 2, followed by option 1.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program, toll-free at 1.800.FDA.1088; by fax at 1.800.FDA.0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or on the MedWatch web site at www.fda.gov/medwatch.
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