Companion 2 Driver System 의 안전성 경고

Safety alert

2012-01-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120110.html

Mhra field safety notice: syncardia companion 2 driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia companion 2 driver system. investigation by the device manufacturer, syncardia systems, inc., of a reported incident revealed that the internal power cable between the main board and power management board had an intermittent connection which caused the companion 2 driver to alarm and lose power. the intermittence was caused by an improper crimp by the supplier on the power cable assembly leads. the problem may result in loss of cardiac output resulting in decreased perfusion of the organs (brain, liver, kidneys etc.). if a patient is not switched to the backup driver in a timely manner, long range health consequences such as organ dysfunction or failure may be resulted. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.