Events

Safety Alert for Companion 2 Driver System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by SynCardia Systems, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-01-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120110.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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.

Device

Companion 2 Driver System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SynCardia Companion 2 Driver System
  • Manufacturer
    SynCardia Systems, Inc.

Manufacturer

SynCardia Systems, Inc.