Events

Retiro De Equipo (Recall) de Transcutaneous blood gas monitor

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 Radiometer Basel AG.

¿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
    22316
  • Fecha de inicio del evento
    2018-01-25
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    The manufacturer has recently received reports of occurrences of the tcm5 causing interferences on ecg and eeg monitors., there is a possibility that tcm5 flex/basic can cause interferences to ecg or eeg measurements, however, only when applied on the same patient. this situation only affects customers who use the tcm5 flex/basic in combination with an ecg or eeg measurement on a patient., latest updated recall action, the manufacturer is advising that other instruments sensitive to electromagnetic interference may be affected by the tc measurement. in a worst-case scenario, the described error may result in insufficient or no treatment for a critically low heart rate or critical arrhythmias.
  • Acción
    Instructions for use to be updated

Device

Transcutaneous blood gas monitor
  • Modelo / Serial
    Model: , Affected: Product code TCM5FLEX/BASIC
  • Manufacturer
    Radiometer Basel AG

Manufacturer

Radiometer Basel AG