Events

Recall of Samaritan PDU 400 (automated external defibrillator)

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

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-00089-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00089-1
  • 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
    The software of samaritan pdu 400 devices may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning the user that the device has insufficient battery to deliver therapy the device may shut down. in such circumstances, an affected device may be unable to operate during a sudden cardiac arrest.This action was undertaken prior to the agreement of the communication by the tga.
  • Action
    Areo Healthcare provided replacement PDU 400 devices to all affected customers.

Device

Samaritan PDU 400 (automated external defibrillator)
  • Model / Serial
    Samaritan PDU 400 (automated external defibrillator)Serial Numbers between 08P00001003 to 11P00007347
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare