Events

Safety Alert for Medical Bed

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

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
    I1603-103
  • Event Number
    2014DM-0011799
  • Date
    2016-03-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=152
  • 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 has detected that by placing a load on the rear section of the bed, the plane may be noisy or lose its functionality due to premature mechanical wear of the actuator, which does not affect the emergency rpc function, but could lead to potentially adverse events. about the patients.

Device

Medical Bed
  • Model / Serial
    AVANTGUARD 1600, serial CS160A0005XXX up to PRS160A0005XXX, manufactured between June 2009 and December 2015.
  • Product Description
    The HILL-ROM 900 and AVANTGUARD 1600 medical beds have been designed for general care, surgery, intensive and post-operative or obstetric care, and allow general or intensive care, as well as using the advanced techniques used in specialized units.
  • Manufacturer
    Hill Rom SAS

Manufacturer

Hill Rom SAS