Events

Recall of CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty Ltd.

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
    RC-2013-RN-00946-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00946-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Maquet cardiopulmonary has determined that in certain rare instances the cardiohelp-i device may display an error message with audible alarm indicating "battery defective". the alarm will occur while booting or when the main power supply is unplugged from the main power source. this is due to a defective capacitor within the battery manager board. further, when alarming the hmi (human machine interface) will gradually become black due to the hmi back light shutting down.
  • Action
    Maquet is advising the customers to only use the Cardiohelp-I on AC power when possible. In the event of a battery defect alarm the AC power should be connected immediately. An upgrade to the sensor panel will be carried out to correct the issue.

Device

CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG...

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA