Events

Recall of HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)

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-00655-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00655-1
  • 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
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • Action
    Aero Healthcare is advising that all the affected units are within the control of the distributors. The distributors are advised that the affected units should be placed in quarantine to await collection by Aero Healthcare.

Device

HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation ele...
  • Model / Serial
    HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)Lot Numbers: A1754, A1795, A1792, A1789, A1802 ARTG Numbers: 161839 (Adult Pad-Pak) and 161841 (Paediatric Pedi-Pak)
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare