Events

Retiro De Equipo (Recall) de Oxylog Emergency Transport Ventilators

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 Draegerwerk AG & Co KGaA.

¿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
    20936
  • Fecha de inicio del evento
    2016-12-15
  • 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
    In december 2015 the manufacturer informed of an error condition obser with the oxylog 3000 and oxylog 3000plus, where the loss of contact of one of the control knobs generated an error message (previously referred to as poti unplugged). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure and the ventilation function stops operating. the error condition was caused by an oxide layer in the potentiometer. oxide layers may accumulate over a longer period of time if various factors collude i.E. if the knobs are moved rarely or never. a verified remedy is repeated twisting of the knobs that removes the oxide layer. remedy of twisting the knob is still considered effective however, to reduce the impact of this error condition the manufacturer has developed new software that reduces the impact of the error condition.
  • Acción
    Software to be upgraded

Device

Oxylog Emergency Transport Ventilators

Manufacturer

Draegerwerk AG & Co KGaA