Events

Field Safety Notices about samaritan® PAD 500P (Public Access Defibrillator)

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
    Field Safety Notice
  • Event Number
    SN2014(12)
  • Date
    2014-03-18
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/samaritan-pad-500p-(public-access-defibrillator)&id=32cdf925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Heartsine technologies is issuing a software upgrade to address an issue that could affect the accuracy of the cpr (cardiopulmonary resuscitation) instructions provided to rescuers by the samaritan® pad 500p during a sudden cardiac arrest situation.
  • Action
    The IMB recommends that:  1. Relevant personnel in your organisation are made aware of this potential issue.  2. Ensure that this IMB Safety Notice and the attached field safety notice is passed on to any organisation or end user where the potentially affected devices have been transferred.  3. Customers should contact either the local distributor or the manufacturer to schedule a service call out to upload the software upgrade to affected devices if a date has yet to be scheduled

Device

samaritan® PAD 500P (Public Access Defibrillator)
  • Model / Serial
  • Product Description
    samaritan® PAD 500P (Public Access Defibrillator)
  • Manufacturer
    HeartSine Technologies

Manufacturer

HeartSine Technologies
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HPRA