Events

Retiro De Equipo (Recall) de Dräger Jaundice Meters

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Draeger Australia Pty Ltd.

¿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
    RC-2018-RN-00325-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00325-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Draeger has determined through post market surveillance activities that some users have concerns about the method used by the jm-103 and jm-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). uncertainty about high value indication may result in delayed treatment of a patient with hyperbilirubinemia.As described in the instructions for use manual and in the device's training materials:- jaundice meter model jm-103 displays a blinking "- - -" when the measurement is out of range. the measuring range is defined to 340 µmol/l; and - jaundice meter model jm-105 displays a blinking "- 0 -" when the measurement is out of range. the measuring range is defined to 340 µmol/l.
  • Acción
    Draeger is providing users with stickers to adhere to JM-103 and JM-105 devices to re-enforce the meaning of the associated blinking units "---" for JM-103 and "-0-" for JM-105 when the measurement is higher than the measuring range of the device. Users are to refer to the instructions provided on the Customer Letter for correct location for the stickers.

Device

Dräger Jaundice Meters
  • Modelo / Serial
    Dräger Jaundice MetersModels Numbers: JM-103 and JM-105 ARTG Number: 152624Draeger Australia - Analyser, bilirubinometer
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd