Trilogy 100 Ventilators 의 안전성 경고

Safety alert

2012-01-13

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120113.html

Fda class i recall: respironics trilogy 100 ventilators the food and drug administration (fda), united states, has issued a class i recall on respironics trilogy 100 ventilators. trilogy 100 ventilators are being recalled due to a manufacturing issue. this issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. in the event of a blower failure, the ventilator will stop delivering therapy and a high priority alarm will sound to alert the caregiver to immediately respond. failure to respond could result in the potential for harm or death of a ventilator-dependent patient. according to the local supplier, the affected product is not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm287528.Htm. if you are in possession of the product, please contact your supplier for necessary actions.