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