Events

Alerta De Seguridad para lifting systems with crane units

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Hill Rom Inc. || Liko Ab.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1605-214
  • Número del evento
    2015DM-0013852
  • Fecha
    2016-05-18
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has identified a possible safety problem due to the failure of the central screw of the sling bar that connects the bar with the crane, the disadvantage is when the medical device is used inadequately, weakening the screw, there is the possibility that it breaks and the patient fall, which could lead to potentially adverse events on patients and / or users.

Device

lifting systems with crane units
  • Modelo / Serial
    Golvo / UNO / Viking - SlingBar 350, SlingBar 450 and SlingBar 600
  • Descripción del producto
    GOLVO: is a versatile crane, designed for use in most lifting situations. LIKORALL: it is a roof motor, it is designed and developed for the complete range of fixed or self-stable lifting systems of LIKO.MULTIRALL 200: it is a flexible roof crane with a versatile range of applications. It moves easily without compromising security and functionality. It is used to transfer from room to room. ROLLON: stand-up standing equipment, which has been developed to carry out safe transfers from and to the position of the seated patient. It is designed for patients with great difficulty in walking and good strength in the arms and ability to carry their weight on the legs. SABINA 200 designed for people with difficulty to stand up for simismas from a sitting position. SABINA II: designed for people with difficulty standing on their own from a sitting position. UNO 102: is a mobile crane with electric raising and lowering of the lift arm. Its use is in post-acute care centers such as nursing homes and other assistance centers. VIKING XS / S / M / L / XL: are two models of flexible mobile cranes that are excellent for small space environments. They are used for common elevationsFREESPAN SR: autonomous lifting system designed for use together with MULTIRALL crane units.
  • Manufacturer
    Hill Rom Inc. || Liko Ab

Manufacturer

Hill Rom Inc. || Liko Ab