Events

Safety Alert for micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580

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

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
    2012-04-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120430a.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
    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.

Device

micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical