Events

Field Safety Notices about Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP

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 Maquet.

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
  • Date
    2016-12-23
  • 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
    Maquet continually monitors the performance of the cardiosave iabps and has discovered an issue that could affect the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidently dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odor, and sparks. it is important to note that to date, there has been no reported patient harm or adverse events attributable to this issue. of the more than 8,000 li-ion batteries distributed worldwide, to date, there have been 3 reported occurrences of the battery venting when dropped. .

Device

Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP
  • Model / Serial
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS