Events

Safety Alert for Samaritan PAD 500P Automated External Defibrillators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by HeartSine Technologies.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-03-04
  • Event Date Posted
    2014-03-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140304a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: heartsine samaritan pad 500p automated external defibrillators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 500p automated external defibrillators, manufactured by heartsine technologies, inc. the affected serial numbers ranged from 10b0010001 to 14b00461703, manufactured between february 2010 and january 2014. according to the manufacturer, the software in the concerned defibrillators 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. to address the issue, the manufacturer has posted an updated version of the software for the samaritan pad 500p on the heartsine technologies website for download. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

Samaritan PAD 500P Automated External Defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartSine Samaritan PAD 500P Automated External Defibrillators
  • Manufacturer
    HeartSine Technologies

Manufacturer

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