Events

Safety Alert for defibrillator Zoll

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

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
    I1411-457
  • Event Number
    2009EBC-0003880
  • Date
    2014-11-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 reports that the tab of the cprstat-padz and cpr-d-padz electrodes can be inserted incorrectly into the connector housing of the multifunction cable, causing an "attach pads" error message, which if not corrected could prevent the download of the equipment, leading to the potential occurrence of adverse events on the patient.

Device

defibrillator Zoll
  • Model / Serial
    SERIE M and SERIE R
  • Product Description
    This product combines a defibrillator with advanced capabilities of ECG monitors and non-invasive transcutaneous rhythm (NTP) with communication, data printing and recording capabilities, designed to support cardiopulmonary resuscitation.
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation