EnVe® ventilator 의 안전성 경고

Safety alert

2012-07-19

2012-07-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120719.html

Medical device safety alert: carefusion enve® ventilator the united states food and drug administration (fda) has posted a safety alert concerning enve® ventilator, manufactured between december 2010 and january 2012, by carefusion. the manufacturer had identified potential risks associated with the enve® ventilator.A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set positive end expiratory pressure (peep) value either intermittently or continuously. the device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. to date, there have been no reports of patient harm associated with the affected devices. for details, please refer to the fda website http://www.Fda.Gov/safety/recalls/ucm312682.Htm. posted on 19 july 2012.