Maquet FLOW-i Anesthesia System C20, C30, C40 의 안전성 경고

Safety alert

2012-07-09

2012-07-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120709.html

Medical device safety alert: maquet flow-i anesthesia system c20, c30, c40 the united states food and drug administration (fda) has issued a class i recall concerning flow-i anesthesia system c20, c30, c40, manufactured by maquet medical systems usa. this action only affected flow-i anesthesia systems distributed between may 2010 and december 2011. 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 corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm310815.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 july 2012.