LUCAS 2 Chest Compression System 의 안전성 경고

Safety alert

2018-02-23

2018-02-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180223b.html

Medical device safety alert: jolife ab lucas 2 chest compression system the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning lucas 2 chest compression system [item number: 3302430-145; multiple affected serial numbers; manufactured between september 2014 and april 2015], manufactured by jolife ab. the manufacturer has become aware of a potential reliability issue where the lucas device may not respond to the push of certain buttons due to potential damage of an internal cable. the user control panel cable can be damaged by rubbing against an adjacent cable connector. if the malfunction were to occur, it may cause the device to exhibit one of the following: the device does not change from one active mode to the other the device does not begin compressions the device does not temporarily stop and lock in the start position when the pause button is pressed the manufacturer will arrange for replacement of an internal cable. users are advised to refer to sections 3.8 and 5.4 of the instruction for use, which states that if there are interruptions, if the compressions are not sufficient, or something unusual occurs during operation: push on/off for 1 second to stop lucas and remove the device from the patient. immediately start manual chest compressions. for details, please refer to the tga’s website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00147-1 posted on 23 february 2018.