Events

Safety Alert for unkown device

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hill Rom 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
    I1409-367
  • Event Number
    2013DM -0010757
  • Date
    2014-09-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=196
  • 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 issues certain recommendations to avoid the deterioration of the coupling systems of the foot section of the device produced by subjecting them to constant knocks and falls, leading to possible possible adverse events on patients or users.

Device

unkown device
  • Model / Serial
    AFFINITY models P3700B, P3700C, P3700D and P3700E, manufactured between October 2006 and June 2014.
  • Product Description
    AFFINITY ™ FOUR obstetric beds are intended to be used as delivery cares for pregnant women with LDR (dilatation, delivery and recovery) or LDRP (dilation, delivery, recovery and postpartum). The hospital systems VERSACA RE ™ and TOTA LCA RE ™ s systems offer patient support perfectly adapted to hospital environments. Care units and intensive surveillance, medical-surgical care, post-anesthesia care unit and deurgery rooms, among others, can be used. The P ROGRESSA ™ bed is designed for the prevention or treatment of pulmonary complications or other associated complications with immobility; for the treatment or prevention of pressure ulcers; or for any other purpose where medical benefits can be obtained from continuous lateral rotation therapy or dermal / percussion therapy.
  • Manufacturer
    Hill Rom Inc

Manufacturer

Hill Rom Inc