HeartStart XL+ (861290) Defibrillator/Monitor 의 안전성 경고

Safety alert

2012-03-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120323.html

Field safety notice: philips heartstart xl+ (861290) defibrillator/monitor medical device manufacturer, philips healthcare, has issued a customer information letter concerning heartstart xl+ (861290) defibrillator/monitor. internal testing showed that when using the device in aed in the following sequence: an alarm condition (e.G. v-fib, v-tach, asystole) occurs the therapy dial is changed from aed mode to any other clinical mode or alarms are enabled in aed mode then any subsequent ecg alarms may not be visible or audible. philips has released a new version of software (a.01.00) that changes the alarm behavior. to mitigate the issue, philips recommends that clinical judgment should be used and the patient’s conditions should be observed when selecting a different clinical mode after aed mode. as an alternative to clear the behavior, exit aed mode and select off, wait ten seconds before entering a different clinical mode. according to the local supplier, the affected devices were distributed to hong kong. the customer information letter will be sent to all affected customers. if you are in possession of the products, please contact your supplier for necessary actions.