Events

Alerte De Sécurité sur Power Wheelchairs

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-07
  • Date de publication de l'événement
    2013-10-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131007b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: invacare power wheelchairs the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning power wheelchairs manufactured by invacare corporation. the following products are affected: invacare power wheelchairs with spj+ joysticks and mk6i driver controls (excluding all asl, sip-n-puff, and switch control systems) invacare power wheelchairs with spj+ joystick models manufactured between 9 september 2009 to 21 march 2013 invacare power wheelchairs with mk6i driver controls (excluding all asl, sip-n-puff and switch control systems) manufactured between 1 october 2006 to 21 march 2013 invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands. invacare is providing distributors with two options to correct the affected joystick: invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to invacare. invacare will engage a third party to complete the correction. distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. invacare will correspond with end users directly if this option is selected. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00977-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 october 2013.

Device

Power Wheelchairs
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Invacare Power Wheelchairs
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation