Events

Rappel de Oxylog Emergency Transport Ventilators

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Draegerwerk AG & Co KGaA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20936
  • Date de mise en oeuvre de l'événement
    2016-12-15
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Oxylog Emergency Transport Ventilators

Manufacturer

Draegerwerk AG & Co KGaA