Events

Safety Alert for Corpatch Easy Pediatric

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

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
    2015-05-11
  • Event Date Posted
    2015-05-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150511a.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
    Medical device safety alert: leonhard lang corpatch easy pediatric australian therapeutic goods administration (tga) posted a medical device safety alert concerning corpatch easy pediatric (defibrillator electrodes), manufactured by leonhard lang gmbh. the affected product code is cp-5120.2 with lot numbers 30708-0777, 30822-0778, 31009-0773, 31121-0774, 40107-0771, 40213-0774, 40222-0773, 40320-0770, 40321-0770, 40324-0773, 40522-0779, 40704-0776, 40808-0773, 40923-0776, 41021-0778 the manufacturer’s internal investigation showed that during the use of these defibrillation electrodes, a possibility for arcing and a resulting malfunction exists. this malfunction can occur with defibrillation electrodes that are older than 2 years. this could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. the precise cause for this is still under investigation. product replacement is on-going. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00388-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2015.

Device

Corpatch Easy Pediatric
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Leonhard Lang Corpatch Easy Pediatric
  • Manufacturer
    Leonhard Lang GmbH

Manufacturer

Leonhard Lang GmbH