Events

Rappel de Laerdal Suction Unit

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 Laerdal Medical AS.

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
    20417
  • Date de mise en oeuvre de l'événement
    2016-08-03
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Cause
    There has been a problem identified that is related to use of the laerdal suction unit (lsu) when used with the lsu nimh battery that hase been stored or installed at low temperatures for a prolonged period., the problem may occur if the lsu with a nimh battery, or the nimh battery, has been stored at low temperatures so that the core temperature of the nimh battery is low, typically between 0 °c and 9 °c (32 °f to 48 °f). if used with a nimh battery with low core temperature, the lsu may shut off after some seconds when operated at 350 mmhg or 500+ mmhg (46.6 kpa or 66.5+ kpa) settings.
  • Action
    Manufacturer to issue advice regarding use

Device

Laerdal Suction Unit
  • Modèle / numéro de série
    Model: 780800 LSU NiMH, Affected:
  • Manufacturer
    Laerdal Medical AS

Manufacturer

Laerdal Medical AS