Events

Safety Alert for BeneHeart D1 Defibrillator/ Monitor

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

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
    2014-11-18
  • Event Date Posted
    2014-11-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118b.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: beneheart d1 defibrillator/ monitor 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.

Device

BeneHeart D1 Defibrillator/ Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BeneHeart D1 Defibrillator/ Monitor
  • Manufacturer
    Mindray

Manufacturer

Mindray