Events

Rappel de James Leckey Design Mygo Stander

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Otto Bock Australia 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-00854-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-29
  • 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-00854-1
  • 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
    It has been identified that the initial design of the angle adjustment mechanism for the stander allowed the user to lock out the safety pull pin on the frame and adjust the angle of the stander using one hand. if the operator’s hand slipped off the turning handle when a patient was in the frame then the handle could “self-wind” and spin rapidly as the stander returns to the upright position. whilst there is no risk to the patient in the frame, the fast spinning handle does pose a risk of injury to the operator if they try to take hold of the handle.These issues only impact devices manufactured between january 2012 and august 2013 as the design of the pull pin safety mechanism was changed in august 2013. it is no longer possible to lock the pull pin out and two hands are now required to adjust the stander angle.
  • Action
    Otto Bock is arranging for distributors to contact users of the affected devices and arrange for replacement of the pull-pin on the device with one that cannot be locked by the operator. The replacement safety pull pin will require the user to hold the pull pin with one hand while turning the adjustment handle with the other hand. If their hand slips off the turning handle, they can simply release the pull pin and the handle will stop winding. For more information, please see https://www.tga.gov.au/alert/james-leckey-design-mygo-stander .

Device

James Leckey Design Mygo Stander
  • Modèle / numéro de série
    James Leckey Design Mygo StanderMygo Stander Size 1Product Code: 143-1600Mygo Stander Size 2Product Code: 143-2600 Serial Number range: LEC/087023 to LEC/108416Manufacture dates: January 2012 to August 2013ARTG Number: 130629
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd