Events

Avis De Sécurité sur Universal SlingBar

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Hill-Rom.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Hill-rom has become aware of a potential safety issue related to the universal slingbar 350, slingbar 450 and slingbar 600 which could be attached to various liko overhead and mobile patient lifts. complaints have been received that the center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. the potentially affected sling bars have been produced until may 2014. analysis has shown that the sling bar is reliable when used as intended with the sling bar level during the lift. however, if the sling bar is not used as intended, the bolt may be weakened. if the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. this hazard could cause potentially minor to catastrophic injuries to a patient. .

Device

Universal SlingBar
  • Modèle / numéro de série
    Universal SlingBar 350, p/n 3156074, 3156084 and 3156094 Universal SlingBar 450, p/n 3156075, 3156085 and 3156095 Universal SlingBar 600, p/n, 3156076 and 3156086 These may be bundled with the Golvo™, Uno™, LikoLight™, Likorall™, Multirall™ and Viking™ XS/S/M/L mobile patient lifts.
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom