hs1 and heartstart frx automatic external defibrillators 의 안전성 경고

Safety alert

2012-11-30

2012-11-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121130.html

Medical device safety alert: philips heartstart hs1 and heartstart frx automatic external defibrillators medical device manufacturer, philips healthcare, has issued an advisory regarding heartstart hs-1 and heartstart frx automatic external defibrillators. the manufacturer has determined that it is important to clarify information in the owner’s manual and keep the users of heartstart frx and hs1 informed about the maintenance of the frx or hs1 heartstart automated external defibrillators (aeds). the manufacturer advised users that in case of single chirps, if the frx or hs1 aed emits a pattern of single chirps(♪...♪...♪...), press the blue i-button on the front of the device for information. the aed will tell the user exactly what actions to take to ensure that the device is ready for use. in case of triple chirps, if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of triple chirps (♪♪♪...♪♪♪...♪♪♪...), it is important that the user remove the device from use, and contact the local philips representative. if an frx or hs1 aed emits a pattern of triple chirps, it is a signal that the device requires investigation by philips to ensure that it is ready for use. of course, if needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the owner’s manual. however, even if the user has been able to clear the error, it is important that the user contact the local philips representative to obtain the tools and information the user need to ensure that the device is functioning properly. users should update their protocols accordingly. in addition, the manufacturer has created a website with additional information about this action. to hear the difference between single chirps and triple chirps emitted by these aeds, visit the manufacturer’s website at www.Philips.Com/heartstartmaintenanceadvisory. according to the local supplier, philips electronics hong kong ltd., the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 november 2012.