Events

Alerta De Seguridad para Schaerer® Surgical table Schaerer® Surgical table Surgical table Surgical table Surgical table Surgical table Schaerer® arcus 501 Schaerer® arcus 601 Surgical table Schaerer® arcus 701 Surgical table : AR-4815, AR-4816, AR-4817, AR-4818, AR-4819, AR-4820, AR-4829, AR-4842.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por H. Strattner e Cia LTDA; Schaerer Medical AG.

¿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
    2271
  • Fecha
    2017-04-19
  • 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
    We recommend observing table movements carefully, and abnormally slow movements should be reported immediately to Schaerer customer service.
  • Causa
    Each schaerer arcus, 501, 601 or 701 surgical table is equipped with a large hydraulic valve block that is mounted to the top of the table column. this valve block is designed to control and coordinate the various hydraulic movements of the surgical table. during the routine quality control procedures at the valve block supplier's factory, inaccurate and out-of-specification drill holes were discovered. these holes serve as a positioner for the hydraulic valves, which control the hydraulic oil flow through the hydraulic system and thus control the movements of the table components. the inaccurate holes can result in damage to the valves, which can result in a table malfunction. the closing of damaged valves can result from an uncontrolled flow of hydraulic oil, which can result in a loss of pressure in the hydraulic pipes and, consequently, the cylinders may lose the correct control. this can result in a complete locking of the operating table in the position it is in.
  • Acción
    Field Action Code TECNOVIG / AC / 01-2017 triggered under the responsibility of the company H. Strattner and Cia LTDA. Company will make correction in the field.

Device

Schaerer® Surgical table Schaerer® Surgical table Surgical table Surgical table Surgical table Su...

Manufacturer

H. Strattner e Cia LTDA; Schaerer Medical AG
  • Source
    ANVSANVISA