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.

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/2012/079
  • Date
    2012-11-19
  • 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-risk-of-failure-to-deliver-therapy
  • 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 caused by two different faults:Some defibrillators may repeatedly turn on and off when not in use, leading to unexpected battery depletion.
    Defibrillators with early versions of the battery management software may switch off after delivering a single shock or give a premature low battery warning.The manufacturer issued a Field Safety Notice (471Kb) (FSN) in September 2012, providing advice on management of the defibrillator.
  • Reason
    (heartsine) may repeatedly turn on and off when not in use, switch off after delivering a single shock or give a premature low battery warning. (mda/2012/079).
  • Action
    Identify affected defibrillators (see below for serial numbers). Increase frequency of checks to daily. If the LED is red or unlit, contact the manufacturer immediately for a replacement defibrillator. Consider relocating the device so that faults are detected promptly. Return the confirmation request in the manufacturer’s FSN issued September 2012 and HeartSine will send you an upgrade kit containing:reserve Pad-Pak (battery) and instruction ‘hang tag’ the software upgrade, USB cable and installation guide.Once the upgrade pack is received follow the instructions to ensure that:a reserve battery pack is available in the carry case for emergency use the ‘hang tag’ with instructions for reserve battery use is attached to the device the software is updated.

Device

Samaritan public access defibrillator
  • Model / Serial
  • Product Description
    Samaritan public access defibrillator.Model: PAD 300/PAD 300P.Manufactured by HeartSine Technologies Ltd.Specific serial numbers are affected.Samaritan PAD 300/300P distributed from August 2004 to December 2010 with a warranted life of up to seven years.The following serial number ranges are affected with one or both of the identified faults.0400000501 to 0700032917 inclusive 08A00035000 to 10A00070753 inclusive 10C00200000 to 10C00210318 inclusiveNote: this range supersedes the one in the manufacturer’s FSN.
  • Manufacturer
    HeartSine

Manufacturer

HeartSine
  • Manufacturer Address
    HeartSine Technologies Ltd Canberra House 203 Airport Road West Belfast BT3 9ED Tel: 028 9093 9400 Fax: 028 9093 9401Email:data@heartsine.co.uk  Website: www.heartsine.com
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA