heartstart xl defibrillator/ monitor battery m3516a 의 안전성 경고

Safety alert

2012-10-03

2012-10-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121003a.html

Medical device safety alert: philips heartstart xl defibrillator/ monitor battery m3516a the medicines and healthcare products regulatory agency (mhra), united kingdom and the health canada posted a medical device safety alert concerning heartstart xl defibrillator/monitor battery m3516a, manufactured by philips healthcare. the affected products were labeled with “made in taiwan” and has “r-2011-12” as date of manufacture code. according to philips, the affected battery may not trigger a low battery alarm on the heartstart xl defibrillator/monitor (m4735a). in this case, if the heartstart xl is used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. there is a potential for patient harm if the xl shuts down or becomes inoperable when in clinical use for providing therapy. therefore, philips recommends the following actions: operate the xl with ac power instead of battery power alone. if it is needed to operate the xl on battery power alone, ensure the battery is from a different date of manufacture (it must not have the r-2011-12 date of manufacture code). if unable to operate with ac power alone or locate a battery with a different date of manufacture than that identified above, use an alternative source for treatment or therapy (i.E., backup defibrillator/monitor). according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the mhra and health canada websites as below: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the products, please contact your supplier for information and necessary actions. posted on 3 october 2012.