Events

Safety Alert Or Field Safety Notices for Samaritan® public access defibrillator

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by HeartSine Technologies.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2014/014
  • Date
    2014-04-29
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-samaritan-public-access-defibrillator-may-miscalculate-the-cardiopulmonary-resuscitation-cpr-rate
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    Risk of failure to deliver therapy.The software in the samaritan® PAD 500P may miscalculate the cardiopulmonary resuscitation (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 the CPR rate is actually at an acceptable level.The manufacturer issued a Field Safety Notice in February 2014 (192Kb) providing advice on this problem.
  • Reason
    (heartsine technologies) rescuer may be incorrectly advised by the device to ‘push slower’ when cpr rate is actually at an acceptable level. (mda/2014/014).
  • Action
    Identify any affected devices. Follow the manufacturer’s instructions in the Field Safety Notice in February 2014 (192Kb) to update to software version 3.4.0. Return the confirmation request to the manufacturer when the software has been updated.

Device

Samaritan® public access defibrillator
  • Model / Serial
  • Product Description
    Samaritan® public access defibrillatorModel: PAD 500PManufactured by HeartSine TechnologiesSpecific serial numbers affectedThe affected devices were manufactured between February 2010 and January 2014 and have a serial number in the range 10B0010001 to 14B00461703 inclusive.
  • Manufacturer
    HeartSine Technologies

Manufacturer

HeartSine Technologies
  • Manufacturer Address
    Mr James McGuinness Heartsine Technologies Ltd 203 Airport Road West Belfast Antrim BT3 9ED Northern Ireland Tel: 028 9093 9400 Fax: 028 9093 9401Email: james.mcguinness@heartsine.com
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA