Events

Notificaciones De Seguridad De Campo acerca de Völker ™ Beds 2080, 2082, S 280, S 282

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 MODS.

¿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
    Our records show that your business has purchased one or more of the beds mentioned above.   hill-rom has received notice that the side rails on the völker ™ 2080 bed accidentally and suddenly drop when the patient leans over the side rail with full body weight. we evaluated the potential risk and determined the possibility of occurrence of less than 9 / 100,000 units or 0.009%. hill-rom wants to remind users of the völker ™ 2080, 2082, s 280 and s 282 bed rails with lateral release buttons for proper use of the side rails. if the patient needs to get out of bed, ensure that the side rails are fully lowered and that they do not directly load the full weight of the body.

Device

Völker ™ Beds 2080, 2082, S 280, S 282

Manufacturer

HILL-ROM MODS