Events

Alerte De Sécurité sur Surgical table for small, medium and high surgery, delivery, obstetrics and orthopedics - Model 683 - ANVISA Registry No. 80009860007

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BARRFAB INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS HOSPITALARES LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1258
  • Date
    2013-05-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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