Events

Alerta De Seguridad para Product: ANGIX DIGITAL ANGIOGRAPHY SYSTEM - Registration: 80260940001 and 80260940003 - Risk Class III - High Risk - Technical Name: Hemodynamic Equipment - Model: ANGIX - All ANGIX serial numbers in Brazil under registration 80260940001 and 80260940003 - (SEE ATTACHMENT)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por XPRO Sistemas LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1457
  • Fecha
    2014-10-13
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Company clarifies that "When performing patient transfer make due blockage of the equipment before commencing patient movement. Lock instruction available in the Angix Operation Manual. ".
  • Causa
    According to the company "(...) during the transfer of the patient from the equipment table to the stretcher where the arc of the equipment crashed against the patient's wrist causing a fracture. in this operation one of the operators who was performing the transposition of the patient lay on the operating console that was not blocked against drives causing undue movement. the operator in question was not a member of the hemodynamic team and had no training in equipment operation. ".
  • Acción
    Company will perform Update, correction or complementation of the instructions for use - Inclusion of addendum to the operation manual with update in the safety information - (LETTER TO THE CLIENTS IN ANNEX) - IMF Code 12213

Device

Product: ANGIX DIGITAL ANGIOGRAPHY SYSTEM - Registration: 80260940001 and 80260940003 - Risk Clas...

Manufacturer

XPRO Sistemas LTDA
  • Source
    ANVSANVISA