heartstart fr3 automated external defibrillators 의 안전성 경고

Safety alert

2012-03-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120306b.html

Field safety notice: heartstart fr3 automated external defibrillators the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning heartstart fr3 automated external defibrillators (aeds) manufactured by philips healthcare. the affected model numbers were 861388 and 861389 and distributed between may 24, 2011 and september 13, 2011. the software on aeds distributed during this time period requires an update, in order to address two urgent aspects. the first can, in an estimated one of 21,000 power cycles, leave the device in an activated but unresponsive state and thus not available for use when needed in an emergency unless the battery is removed and reinstalled. the second can result in a language loaded onto the fr3 that is different than the language selected by the user during the language load process. the manufacturer will provide an fr3 software update kit to correct the above two aspects. 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.