Events

Recall of Heartsine PAD300 & PAD300P Auto External Defibrillators

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Heartsine Technologies 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
    13525
  • Event Initiated Date
    2012-09-27
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Amtech Medical Ltd, 281 Heads Road, Wanganui 4501
  • Reason
    The manufacturer advises there are two issues with these devices;, 1) the device may turn itself on without input from the user, potentially depleting the battery., 2) some versions of the battery management software may interpret a temporary drop in battery voltage as signalling a low battery and turn the device off.
  • Action
    Software to be upgraded

Device

Heartsine PAD300 & PAD300P Auto External Defibrillators

Manufacturer

Heartsine Technologies Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA