Events

Safety Alert for Surgical table for small, medium and high surgery, delivery, obstetrics and orthopedics - Model 683 - ANVISA Registry No. 80009860007

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BARRFAB INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS HOSPITALARES LTDA.

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
    1258
  • Date
    2013-05-09
  • 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
    An investigation was carried out which resulted in the incorrect use of the oil that impaired the performance of the actuator of the elevation, generating a decrease in system performance. For further information: E-mail: administracao@barrfab.com.br; Phone: 54-2628-8808; Correspondence: Rua Mario Ely, 271 - Fiftieth anniversary - Farroupilha - RS- CEP: 95180-000. Access to the letter, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/6ff373004f8f339d868bf79a71dcc661/Carta_Cliente.pdf?MOD=AJPERES
  • Reason
    Observed during laboratory test failure, in items 20 of iec 60601 and 21.101 of iec 60601-2-46. during the test of item 20 there was reduction of dielectric strength, by crushing the power cable. for item 21.101 there was loss of performance of the lift actuator, which yielded with 482kg.
  • Action
    Notice to customers and authorized representatives; Evaluation with the customers of the possibility of replacing components.

Device

Surgical table for small, medium and high surgery, delivery, obstetrics and orthopedics - Model 6...

Manufacturer

BARRFAB INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS HOSPITALARES LTDA