Events

Field Safety Notices about Maquet / Datascope CS100i and others

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 Getinge.

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
    2017-06-19
  • 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 / getinge received a complaint that the cs300 iab had stopped pumping due to electrical error code # 58 (insufficient current on valve coils), maintenance error code # 3 and self-incapacitation, which resulted in the death of the patient as he did not receive adequate mechanical therapy or support.

Device

Maquet / Datascope CS100i and others
  • Model / Serial
    0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX; 0998-UC-3013-XX 0998-00-3023-XX; 0998-UC-3023-XX
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Getinge

Manufacturer

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