Events

Rappel de Mutiple Laerdal Suction Units (LSU) with NiMH Battery

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Laerdal Pty Ltd.

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
    RC-2016-RN-00973-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00973-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Laerdal medical has become aware of a problem related to the use of the laerdal suction unit (lsu) when used with the lsu nimh battery that has 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 itself, when the core temperature of the battery is low, typically between 0°c and 9°c. 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. if nimh battery has been stored at temperatures above 9 °c, and used at low temperatures, use should not be affected.
  • Action
    Laerdal is providing users with the optimised vacuum settings depending on the battery core temperature. Users are advised to install or store the batteries in locations where temperatures are above 9°C.

Device

Mutiple Laerdal Suction Units (LSU) with NiMH Battery
  • Modèle / numéro de série
    Mutiple Laerdal Suction Units (LSU) with NiMH BatteryLSU with Resuable Canister Product Code: 78000003 LSU with Abbot Receptal canister Product Code: 78001003 LSU with Bemis Canister Product Code: 78002001 LSU with Serres Suction Bag Canister System Product Code: 78003003 All serial numbers affectedARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd