Events

Alerta De Seguridad para Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series numbers affected in Brazil-distributed in the Municipality of São Paulo-SP: 99; 142; 144; 145 distributed in the Municipality of Rio de Janeiro-RJ: 239; 241; 243.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH.

¿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
    1856
  • Fecha
    2016-04-14
  • 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
    Recommendations to users and patients: Check at the time of use of the equipment whether the basic table top is locked on the conveyor or if it needs to be transferred to the conveyor, make sure that the extension device is attached to the side opposite the battery holder and conveyor belt bar. ### UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    Maquet within the scope of market surveillance has learned that, due to improper handling under unfavorable circumstances, the magnus 1180 table extension device can be unlocked from the tabletop and fall. this problem may occur when the device is not used according to the description in the instructions for use and the operator does not pay attention to possible collisions. in extreme cases, collisions with an obstacle under the tabletop can lead to the problem described above. the extension device may from the operating table mounting point if: • the table top with mounted accessories is moved against obstacles; • the assembled table top with accessories is transferred to the conveyor incorrectly with the foot and head ends inverted.
  • Acción
    Code of the action CAPA 2016-002. Send of letter of report for the customers that have equipment affected ////// Sending of technicians to the place of equipment affected for installation of new accessory.

Device

Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series nu...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA