Events

Recall of Heartsine Samaritan PAD 500P Automatic External Defibrillator

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
    16329
  • Event Initiated Date
    2014-03-07
  • 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 software in the 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
    Software to be upgraded

Device

Heartsine Samaritan PAD 500P Automatic External Defibrillator
  • Model / Serial
    Model: Model PAD 500P, Affected: Manufactured between Feb-2010 and Jan-2014
  • Manufacturer
    Heartsine Technologies Ltd

Manufacturer

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