Events

Safety Alert for Adult and Pediatric Discharge Electrodes Used with External Automated Defibrillator Samaritan PAD

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Heartsine Technologies Limited.

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
  • Event ID
    R1408-332
  • Event Number
    2010EBC-0005940
  • Date
    2014-08-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=197
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer determined that the aluminum bags containing the electrodes are difficult to open which can cause delayed defibrillation or cardioversion therapy, leading to possible adverse events being generated on the patient.

Device

Adult and Pediatric Discharge Electrodes Used with External Automated Defibrillator Samaritan PAD
  • Model / Serial
    Reference Pad - Pak and Pediatric - Pak, lots A1785 up to A1805 and P433 up to P445 respectively, distributed from || May 15, 2014 with new equipment or as a substitute for || consumables
  • Product Description
    It is used to perform electric shocks in cases of cardio-respiratory arrest and fibrillation.
  • Manufacturer
    Heartsine Technologies Limited

Manufacturer

Heartsine Technologies Limited
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA