Events

Retiro De Equipo (Recall) de HIRES 90K

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ADVANCED BIONICS LLC.

¿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
  • ID del evento
    26993
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-06-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Advanced bionics (ab) is notifying implant surgeons about the removable magnet component of the hires 90k cochlear implant (model no. ci-1400-01 and ci-1400-02h). the magnet is designed to be surgically removable if the cochlear implant patieint needs to undergo an mri. ab reports that devices manufactured between may27 and june30 of 2005 may have a magnet laser welding defect. the magnets were made such that the metal case surrounding the magnet is not properly welded. a patient implanted an unwelded magnet could experience a decrease in the strength of the magnet over time leading to headpiece retention issues. ab is aware of 14 defective magnets. in 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in canada. an additional 5 potential cases outside of canada and the usa are under investigation. based on random sampling ab has determined the weld failure occurred at a rate of 1 in 126 devices. devices manufactured outside the above time frame were not affected.

Device

HIRES 90K
  • Modelo / Serial
    Model Catalog: CI-1400-01 (Lot serial: N/A); Model Catalog: CI-1400-02H (Lot serial: N/A); Model Catalog: CI 1400-01 (Lot serial: N/A)
  • Descripción del producto
    REMOVABLE MAGNET HIRES 90K
  • Manufacturer
    ADVANCED BIONICS LLC

Manufacturer

ADVANCED BIONICS LLC
  • Dirección del fabricante
    SYLMAR
  • Empresa matriz del fabricante (2017)
    Sonova Holding Ag
  • Source
    HC