Events

Retiro De Equipo (Recall) de BABYTHERM 8000 LDR WARMING BED

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
    26564
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-25
  • 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
    As part of draeger's market and product monitoring they have become aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. the side panel did not open during this incident and no patient was affected. when reviewing the locking mechanism in a number of hospitals it was possible to fully close the side panels by pushing down on them slightly. however it cannot be guaranteed that the panel will lock into position under its own wieght.

Device

BABYTHERM 8000 LDR WARMING BED
  • Modelo / Serial
    Model Catalog: FR00050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00120 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00098 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FR 00114 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    BABYTHERM 8000 LDR WARMING BED
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

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