Events

Safety Alert for VERSACARE Hospital bed, ANVISA registration no. 80102510055.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil 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
    847
  • Date
    2006-12-06
  • 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
    There were 13 incidents, all in the US and none in the country. Inquiries or information, contact VR Medical: Phone (11) 3887-6640 / 3889-0875; e-mail verarosas@verarosasregistro.com.br; www.verarosasregistro.com.br. Letter sent to clients: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/847.pdf
  • Reason
    Potential risk of injury involving the versacare hospital bed.
  • Action
    VR Medical Importadora e Distribuidor de Produtos Médicos Ltda. Has sent letters to all product owners and their distributors, notifying them of the inconvenience with the cable length of the remote control. This letter included instruction on how to solve the problem, warning labels, hooks and plastic ties in order to attach the cable to the bed frame.

Device

VERSACARE Hospital bed, ANVISA registration no. 80102510055.

Manufacturer

Hill Rom Inc
  • Source
    ANVSANVISA