Events

Recall of Maquet Cardiosave Hybrid and Rescue IABP

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Maquet Critical Care AB.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19936
  • Event Initiated Date
    2016-03-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    The alarm te63/64 is generated during some circumstances when the flow -i-anaesthesia systems considers that the internal communication does not work as intended. this falsely triggered technical alarm results in that the vaporiser is turned off due to burning issue between the sub systems.
  • Action
    Software to be upgraded

Device

Maquet Cardiosave Hybrid and Rescue IABP
  • Model / Serial
    Model: FLOW-i C20 FLOWE-i C30 and FLOW-i C40, Affected: Part Nos: 66 77 200 ,66 77 300 and 66 77 400
  • Manufacturer
    Maquet Critical Care AB

Manufacturer

Maquet Critical Care AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA