Events

Safety Alert for Pneumatic beds, home use, Cliniton, model CS and C-6, All serial numbers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hill-Rom Co Inc A Hillenbrand Industry.

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
    322
  • Date
    2001-11-02
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The electrical wires in the above beds may become hot, smoke or melt during normal operation. the manufacturer initiated a patch distributing the replacement wires and ups instructions to the home of all patients with affected beds. in addition, all service centers have received an inventory of wires to exchange current wires in their service centers.
  • Action
    Service centers must verify that they have received Hill-Rom substitutes. Hill-Rom technicians are following the patients to see if correction procedures have been performed. If there is any affected product in your inventory that still has an affected cord or if you would like more information, contact your local representative

Device

Pneumatic beds, home use, Cliniton, model CS and C-6, All serial numbers.

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA