Events

Retiro De Equipo (Recall) de unkown device

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por N/A.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2004-04-08
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/alerte-sur-les-lits-medicaux-electriques-equipes-de-pedales-de-commande-de-hauteur-variable
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    Due to the persistence of reports of serious incidents related to an involuntary activation of a movement of the electric bed by acting on the variable height control pedal, the Afssaps broadcasts the alert attached (08/04 / 2004) (116 KB) at destination. health facility directors and local correspondents for materiovigilance for dissemination to technical, biomedical, purchasing and care services. the Directorate-General for Social Action for dissemination to the directors of institutions for the elderly and disabled. Each establishment must proceed or have the variable height pedals on the electric medical beds inactivated according to the specific protocols established by the manufacturers. The inactivation procedures that were provided to us by the manufacturers are available from the list below. The other competent European authorities have been informed of this measure. . List of manufacturers distributing in France beds equipped with variable height control pedals. updated: 13/05/0. To obtain the protocol (pdf format), click on the name of the manufacturer. . WORKSHOPS OF UPPER FOREZ (01/01/1970) (0 KB MATIFAS (07/04/2004) (2329 KB CORONA (14/04/2004) (615 KB MEDICATLANTIC (13/04/2004) (151 KB EDENA (13/04/2004) (1629 KB) MEYRA - no product distributed in English HILL-ROM (14/04/2004) (2972 KB MMO (08/04/2004) (1146 KB) EST ( 07/04/2004) (4554 KB SOTEC (08/04/2004) (118 KB MALVESTI TASSERIT (13/05/2004) (8 KB)

Device

unkown device
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM