Carry Case used with the HeartStart FR3 Automated external defibrillator (AED) 의 안전성 경고

Safety alert

2012-03-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120306a.html

Field safety notice: carry case used with the heartstart fr3 automated external defibrillator (aed) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the carry case used with heartstart fr3 aed, manufactured by philips healthcare. according to the manufacturer, the heartstart fr3 aed itself is not part of this action. only the small soft carry cases [model numbers 989803173711 (philips) and 989803173721 (laerdal)] manufactured by philips and shipped between may 2011 and august 2011 are part of this action. all small soft cases, models 989803173711and 989803173721, are affected. the model number can be found on the carry case label, located directly under the fr3 when it is stored in the case. the affected small soft carry cases incorporate a magnet in the lid that automatically turns the fr3 aed on when the case is opened. if the case is not aligned properly when closed, the fr3 may interpret the resulting intermittent misalignment of the magnet as a case opening. thus, the aed may turn on repeatedly while stored in the case, inadvertently depleting the battery. the manufacturer warned users that a drained battery may not allow the fr3 to deliver therapy in case of an emergency. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.