Alerta De Seguridad para Pediatric Bed Structure Model E-1943 HARD

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HARD Mfg Co Inc.

¿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
    241
  • Fecha
    2000-12-29
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reported that in examining a problem with the bed frame structures mentioned, maintenance staff discovered a crack in the corner joint weld (ie, an area where two or more pieces of metal are welded). the hospital claims that the units were in use for about six months only. the nurses were not aware of the problem, and as a result, the hospital can not determine when the cracks occurred. the hospital says that the manufacturer hard changed the bed structures and that no other unit presented the problem.
  • Acción
    ECRI makes the following recommendations: (1) Periodically inspect all welds in cribs for wear or cracks. The HARD manufacturer recommends annual inspections, but ECRI believes that semiannual inspections are more appropriate. The manufacturer HARD says it will inspect the beds produced by them in their hospital for free. (2) Remove any cracks where any cracks appear and contact your local dealer or directly with the HARD manufacturer for replacement of the frame. ECRI states that preventive maintenance procedures are available in a free manual provided by the manufacturer HARD; the manual also includes prior risks and crib alerts, as well as the current FDA product regulations. Contact your local dealer or directly with the HARD manufacturer by mail for the manual or to inquire about inspection services.

Device

Manufacturer

  • Source
    ANVSANVISA