Life Pulse High-Frequency Ventilator Patient Circuits 의 안전성 경고

Safety alert

2012-12-06

2012-12-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121206.html

Medical device safety alert: bunnell life pulse high-frequency ventilator patient circuits the united states food and drug administration (fda) posted a firm press release concerning life pulse high-frequency ventilator patient circuits, manufactured by bunnell incorporated. bunnell incorporated voluntarily initiated a nationwide recall notification of life pulse high-frequency ventilator patient circuits. the product has been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. there have been 12 reported failures out of 5,771 patient circuits distributed. although there have been no reports of patient injury or death the manufacturer informs clinicians to be aware of the potential that a patient circuit failure could result in patient injury or death as a precautionary measure. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm330842.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 december 2012.