Events

Recall of Defibrillator/pacer SLIM corpuls3

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2014-RN-00979-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00979-1
  • 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
    Due to too little distance between a circuit board and the housing, there is the possibility that a component on that circuit board could be damaged mechanically. this impairs the radio connection between the modules. the user can recognise this, if a respective error message (ie, “no connection to defibrillator unit” or “no connection to p-box” ) is displayed. impairment of the radio connection between the modules could result in the inability to: - perform full patient monitoring; and - correctly adjust and operate a therapy function of the device. vibrations have been found to increase the likelihood of this malfunction. due to this issue, diagnosis and therapy are delayed, because the measurement and therapy functions cannot perform without problems.
  • Action
    Device Technologies Australia (DTA) is advising the customer to connect the module mechanically to form a compact device if the error message is displayed. A permanent correction of the error is only possible by replacing the affected radio module. DTA is arranging replacement of the radio module. This action has been closed-out on 1/06/2016.

Device

Defibrillator/pacer SLIM corpuls3

Manufacturer

Device Technologies Australia Pty Ltd