Safety Alert for atar extension cable

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    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.