Events

Safety Alert for Fan - IMPACT / ZOLL

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

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
    A1707-260
  • Event Number
    2009EBC-0003133
  • Date
    2017-07-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=80
  • 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 it has detected that biomedical equipment can lead to a configuration change inadvertently in the configuration of the device during normal operation, changing the ventilatory parameters in bi-level and cpap mode, requiring the intervention by the medical assistance staff to restore them, leading to to the possible occurrence of adverse events on patients.

Device

Fan - IMPACT / ZOLL
  • Model / Serial
    UNI-VENT 731 EMV SERIES, software version 05.20.00
  • Product Description
    This equipment provides ventilatory support to patients with some type of respiratory disease that must be moved from one place to another.
  • Manufacturer
    Impact Instrumentacion, Inc.

Manufacturer

Impact Instrumentacion, Inc.