Defibrillator/pacer SLIM corpuls3 의 안전성 경고

Safety alert

2014-09-17

2014-09-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140917.html

Medical device safety alert: device technologies defibrillator/pacer slim corpuls3 the australia therapeutic goods administration (tga) posted a medical device safety alert concerning defibrillator/pacer slim corpuls3 (product code: cp-4301) manufactured by device technologies. according to the alert, there is the possibility that a component on that circuit board could be damaged mechanically due to too little distance between a circuit board and the housing. this impairs the radio connection between the modules. the user can recognise this, if a respective error message (ie. “no connection to defibrillator unit” or “no connection to p-box”) is displayed. in rare cases this can result in impairment of the radio connection between the modules, and then it is no longer possible to: a) perform full patient monitoring; and b) correctly adjust and operate a therapy function of the device. vibrations have been found to increase the likelihood of this malfunction. due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems. the manufacturer is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. a permanent correction of the error is only possible by replacing the affected radio module. the manufacturer is arranging replacement of the radio module. for details, please refer to tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00979-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 september 2014.