micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 의 안전성 경고

Safety alert

2012-04-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120430a.html

Field safety notice: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580. the manufacturer has observed a small population of ref 4580 in which a component has not performed as well as expected. it has been reported to the manufacturer that some users of the device have encountered the failure of a mosfet which can affect output of the device. typical failure has been seen where output has been compromised on either the atrial or ventricular channel of the device. after reviewing two recent incident reports and following to “bench testing” of the device, the manufacturer has decided to make a voluntary, proactive decision to modify the product by changing a mosfet component. according to the manufacturer, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.