Events

Retiro De Equipo (Recall) de BABYTHERM 8004/8010

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DRAEGER MEDICAL CANADA INC..

¿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
    92075
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-27
  • 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
    Draegerwerk ag&co kgaa the parent company of draeger medical canada inc. became aware of a case in which a babytherm 8004 open care warmer was operated in skin temperature mode with skin temperature sensor to prepare it for use. there was no patient in the warmer at the time. in skin temperature mode the radiant warmer output is controlled automatically until the set skin temperature is reached. as a result of operating the temperature sensor without patient contact the radiant warmer was operated continuously at a high output level. during this forced continuous operation under high thermal load the heating element aged faster. as a result a piece of the heating element detached and fell onto the mattress tray where a towel ignited. there were no reported injuries.

Device

BABYTHERM 8004/8010
  • Modelo / Serial
    Model Catalog: FR 00114 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00098 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00120 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    BABYTHERM 8004/8010
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    HC