Events

Alerte De Sécurité sur Swift Mobil Shower Chair

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

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
    2012-11-22
  • Date de publication de l'événement
    2012-11-22
  • 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_20121122a.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: etac swift mobil shower chair it has come to our attention that medical device manufacturer, etac supply center ab has issued afield safety notice regarding all swift mobil shower chairs with serial number 3829 to 11028. the manufacturer has received information from a few users of malfunctions with the swift mobile shower chair. it was reported that the casters in some cases are loose and in a few cases has fallen off. the manufacturer is unaware that loose casters would have resulted in any harm or serious injuries. there is however a potential risk for harm and injury if the shower chair loses a caster and thus instantly becomes unstable. the manufacturer has after thorough investigation concluded that several root causes has contributed to the reported loosening of casters. the required torque for the caster fastening screws to the frame has in some cases not met the factory specifications. therefore, the manufacturer will replace the casters of the affected shower chairs to ensure a continuous long term safe use. also, the manufacturer advised that there are no reasons for an immediate stop of using the affected product, however as an intermediate precautionary action awaiting the caster replacement, user facilities are requested to be observant and inspect the casters to see if there are visible signs of a caster coming loose. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 november 2012.

Device

Swift Mobil Shower Chair
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Etac Swift Mobil Shower Chair
  • Manufacturer
    Etac Supply Center AB

Manufacturer

Etac Supply Center AB