The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Cardiocom Commander FLEX, manufactured by Cardiocom LLC. The affected model is CD310.
The manufacturer has received one complaint of a power supply adaptor breaking apart while in a patient's use. This power supply adaptor is purchased by the manufacturer and used with the Cardiocom Commander FLEX in the United Kingdom (UK). All Commander FLEX devices that are distributed in the UK are affected by this recall; these include serial numbers 1000400200 through 1000400264.
According to the manufacturer, there are a potential for serious injury or death in this defect. When the adaptor is damaged, a portion of the plugin remains in the wall socket. This broken adaptor presents a serious risk of electrical shock that could prove fatal.
The manufacturer is advising users not to touch the affected products or otherwise come into contact with the adaptor if breakage occurs and also not to unplug the adapter, or to plug it in if the user had not already inserted it into the wall socket.
The manufacturer will exchange the defective adaptor and replace an adaptor that does not have the same risk of damage to customers. Once the exchange has been completed, users may resume the use of the Commander FLEX as they normally would, pursuant to the instructions for use for the medical device.
For details, please refer to MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON406390
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 April 2014