Events

Field Safety Notices about Beneview T1

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Shenzhen Mindray Bio-Medical Electronics Co., LTD.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Mindray has identified the possibility of overheating of lithium-ion rechargeable batteries used for the beneview t1 life monitor. initial reporting of malfunction and clinical evaluation have shown that the problem is overheating of the battery, the appearance of smoke, which, in exceptional circumstances, can cause the housing to melt.

Device

Beneview T1

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co., LTD