Ondal AC2000 Spring-Loaded Arm 의 안전성 경고

Safety alert

2014-04-01

2014-04-01

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140401.html

Medical device safety alert: draeger ondal ac2000 spring-loaded arm the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ondal ac2000 spring-loaded arm, manufactured by draeger and up until the end of 2006. the affected part numbers are g19051, g19262, g93358 and g93359. the manufacturer has received case reports where a welded seam in the spring-loaded arm of the monitor holder broke. investigations revealed that the welded seam in the spring-loaded arm was unable in isolated cases to withstand the dynamic stress over years where monitors were frequently moved. the monitor is then at risk of falling. although no injury was reported, the risk of injury to persons positioned beneath the monitor cannot be excluded. the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394667 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 01 april 2014.