Events

Safety Alert for defibrillators cardiolife TEC-8300K series

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

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
    2012-08-14
  • Event Date Posted
    2012-08-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120814a.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: nihon kohden defibrillators cardiolife tec-8300k series the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of defibrillators cardiolife tec-8300k series (model no.: tec-8321k, tec-8322k, tec-8332k, tec-8342k and tec-8352k), manufactured by nihon kohden corporation. according to the manufacturer, there is a possibility for a limited number of cardiolife defibrillators tec-8300k series that the battery is not charged when the defibrillator is connected to the ac power. the defibrillator can be used in the battery operating mode until the battery is discharged completely. there is no limitation for the operation of the defibrillator when ac power is connected. 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. posted on 14 august 2012.

Device

defibrillators cardiolife TEC-8300K series
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Nihon Kohden defibrillators cardiolife TEC-8300K series
  • Manufacturer
    Nihon Kohden Corporation

Manufacturer

Nihon Kohden Corporation