Events

Safety Alert for Defibrillation Electrode SKINTACT DF29N

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

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
    2016-09-20
  • Event Date Posted
    2016-09-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160920.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 defibrillation electrode skintact df29n the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning defibrillation electrode skintact df29n manufactured by leonhard lang. the affected article number is 50028. during an investigation triggered by customer feedback, the manufacturer discovered that it can be aggravated to connect these defibrillation electrodes with the defibrillator welch allyn aed 10. as a consequence, it may happen that the user does not connect the electrodes with the defibrillator in an emergency situation. according to the manufacturer, there is a risk that the affected electrodes will be connected with the defibrillator only with delay or not at all. this may cause a situation in which a patient, who is in a life-threatening condition and requires a defibrillation shock, cannot be treated in good time. the manufacturer advises users to quarantine and destroy all unused affected products. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-12-16-september-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 september 2016.

Device

Defibrillation Electrode SKINTACT DF29N
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Leonhard Lang Defibrillation Electrode SKINTACT DF29N
  • Manufacturer
    Leonhard Lang

Manufacturer

Leonhard Lang