atar extension cable 의 안전성 경고

Safety alert

2017-07-07

2017-07-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170707.html

Medical device safety alert: atar extension cable the food and drug administration (fda), united states has posted a medical device safety alert concerning atar extension cable, reusable and disposable models, manufactured by oscor. during the use of some atar extension cables, the cable was separating from the connector at the proximal end. the analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. this event resulted in cable malfunction, causing interruption of the pacing system. according to the manufacturer, they received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. no deaths were reported; however the risk for possible injury is a concern if the cable separates during use. for pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. continuous monitoring is required. product recall is on-going. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm566006.Htm https://www.Fda.Gov/safety/recalls/ucm566001.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 july 2017.