Events

Rappel de Liko Multirall 200 overhead lift and S65 Carriage

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom 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-2017-RN-01289-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-18
  • 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-2017-RN-01289-1
  • 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
    Hill-rom has become aware of a user-error of improper attachment of the multirall 200 overhead lift to the s65 carriage that could result in a potential safety issue. since the introduction of this combination in 2007, twenty six events have been reported where an improper connection of the s65 carriage to the multirall 200 overhead lift was not identified by the user prior to use and a disconnect occurred, resulting in the unit falling. eleven of these cases have alleged injuries to the caregiver or patient.Hill-rom would like to reinforce that the instructions relating to proper connection, including verification of proper attachment prior to use, must be followed when attaching the multirall 200 overhead lift to the s65 carriage. the instructions for proper connection are included in the instruction guide provided with the liko multirall 200 overhead lift and s65 carriage.
  • Action
    Hill-Rom is advising users to refer to the instructions for use and additional Quick Reference Guide to aid in correct installation of the Multirall 200 overhead lift to the S65 carriage. The Quick Reference Guide also provides a link to a video that users should view for system installation/use.

Device

Liko Multirall 200 overhead lift and S65 Carriage
  • Modèle / numéro de série
    Liko Multirall 200 overhead lift and S65 CarriageMultirall 200 overhead lift Product Number: 3130001S65 CarriageProduct Number: 3136011All Serial NumbersARTG Number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd