IW900-series Infant Warmers 의 안전성 경고

Safety alert

2014-11-06

2014-11-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141106a.html

Medical device safety alert: fisher & paykel healthcare iw900-series infant warmers it has come to our attention that medical device manufacturer, fisher & paykel healthcare, has initiated a field safety corrective action concerning some of its iw900-series infant warmers. there were two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. users should check whether they have the affected infant warmers and the spare parts. the manufacturer is supplying replacement pivot securing nuts to all affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.