Events

Retiro De Equipo (Recall) de Draeger Jaundice Meter JM 103

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Draeger Medical Systems 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
    22800
  • Fecha de inicio del evento
    2018-04-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Causa
    Post market surveillance has shown that some users have concerns about the method used by jaundice meters jm-103 and/or jm-105 to indicate that a taken measurement is out of range. 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., 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
    Manufacturer to issue advice regarding use

Device

Draeger Jaundice Meter JM 103

Manufacturer

Draeger Medical Systems Inc