Events

Notificaciones De Seguridad De Campo acerca de Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts

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
    Hill-rom has received 9 complaints where it is alleged that the lift arm drifted down suddenly on certain viking® mobile lifts. this issue is preceded by users who lift the lift arm assembly manually, as shown in the illustration to the right. the lift arm assembly is intended to only be lifted by the actuator (lift motor). if the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. when the actuator is stuck, the lift cannot be raised/lowered by the lift motor. if a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient. this hazard could cause minor or potentially catastrophic injuries to a patient if the free fall encompasses the entire stroke of the actuator. .

Device

Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts

Manufacturer

HILL ROM MODS