Events

Rappel de Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)

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-01529-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-24
  • 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-01529-1
  • 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 on/off functionality of the lcsu 4. the on/off functionality is controlled by electronic components and one of these components might be damaged. the damage occurs over time when the unit is connected to a power source (battery or external power source), but is not related to frequency of use. a damaged component will result in failure of the on/off functionality whereby the lcsu 4 cannot be turned off, and it may turn on by itself. the unit can be turned off by removing the battery or the external power source.
  • Action
    Laedral will be providing replacement units. In the interim, Laedral is advising users to perform a test to identify if their unit has failing On/Off functionality, by turning the unit on then turning it off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component and the device should be taken out of service. If the unit passes the test, the device can continue to be used until the replacement unit is received, but the following extra safety measures should be implemented: - Store the LCSU 4 unit without the battery connected. - Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. If the On/Off functionality fails during clinical use, the unit can continue to be used so long as it has power. The unit can be turned off by removing the battery or the external power source.

Device

Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)
  • Modèle / numéro de série
    Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)LCSU 4, 300ml Complete unitItem Number: 88006140LCSU 4, 800ml Complete unitItem Number: 88005140 Units manufactured from 1 May 2015 to 28 October 2016 that do not have 'RW' on labelARTG Number: 205931
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd