The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning BeneHeart D1 Defibrillator/ Monitor, manufactured by Mindray. The affected product is BeneHeart D1 with the first four digits of the serial number as FQ37/ FQ38/ FQ39/ FQ3A/ FQ3B/ FQ3C/ FQ41/ FQ42/ FQ43/ FQ44/ FQ45/ FQ46/ FQ47.
The manufacturer has identified the affected AEDs might fail to boot. When this issue occurs, the status indicator of the AED is off. The reason for the startup failure of the AED is due to abnormal reset of the power management circuit on the main control board.
The manufacturer advises affected users to discontinue use of the AED. The manufacturer will repair the affected AEDs as soon as possible.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON473632
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 November 2014