Events

Notificaciones De Seguridad De Campo acerca de Universal SlingBar

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Hill-Rom.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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