Powerheart G5 Automated External Defibrillator (AED) Electrode Connector 의 안전성 경고

Safety alert

2014-02-05

2014-02-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140205.html

Mhra field safety notice: cardiac science powerheart g5 automated external defibrillator (aed) electrode connector the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning powerheart g5 automated external defibrillator (aed) electrode connector manufactured by cardiac science corporation (csc). the aeds, shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. the affected models include powerheart g5s and g5a aeds. according to csc, some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognize that pads have been placed on the patient during a rescue attempt. if the issue occurs, the aed may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. this could lead to serious adverse health events or death. csc will be arranging for repair of affected devices for users. according to the local supplier, pacific medical systems, the affected devices were not distributed in hong kong. for details, please refer to the following link: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con370003.Pdf if you are in possession of the affected product, please contact your supplier or pacific medical systems for necessary actions. posted on 05 february 2014.