Reusable Breathing Circuit 의 안전성 경고

Safety alert

2013-01-08

2013-01-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130108.html

Medical device safety alert: fisher and paykel reusable breathing circuit the united states food and drug administration has issued a medical device safety alert concerning reusable breathing circuit [model no.: 900mr068 & lot no.: 110810 & 111020], manufactured by fisher and paykel healthcare ltd. according to the manufacturer, the tubes used in the reusable breathing circuit have pinholes. if these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. usage of the defective device may result in patient death. customers were instructed to examine their inventory and destroy and discard any affected circuits in possession. replacement circuits will be provided to customers. according to the local supplier, the affected products were not distributed in hong kong. for further details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm334446.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm334297.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 january 2013.