EnVe Ventilators 의 안전성 경고

Safety alert

2011-10-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111020.html

Fda class i recall: carefusion enve ventilators medical device company, carefusion, recalls enve™ ventilators manufactured between december 2010 and may 2011. the fda has classified this action as a class i recall. the company identified potential risks associated with the enve ventilators. the issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. carefusion is conducting a field corrective action to update the hardware and software on affected ventilators. for details, please refer to the fda website http://www.Fda.Gov/safety/recalls/ucm276704.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.