Events

Recall of Samaritan PAD 500P (Public Access 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-00243-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00243-1
  • 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 in the affected samaritan® pad 500p may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level.
  • Action
    Aero Healthcare is advising users not to remove devices from service. Aero Healthcare is advising users that to address the issue an updated software version is available on the HeartSine Technologies website for download. Please follow the instructions provided by Aero Healthcare to download the new software. Alternatively, Aero Healthcare can provide an upgrade kit which includes a CD with the updated software version.

Device

Samaritan PAD 500P (Public Access Defibrillator)
  • Model / Serial
    Samaritan PAD 500P (Public Access Defibrillator) Serial Numbers: 10B0010001 to 14B00461703Manufactured between February 2010 and January 2014ARTG Number: 156690
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare