Events

Alerte De Sécurité sur lifting systems with crane units

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Hill Rom Inc. || Liko Ab.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1605-214
  • Numéro de l'événement
    2015DM-0013852
  • Date
    2016-05-18
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Golvo / UNO / Viking - SlingBar 350, SlingBar 450 and SlingBar 600
  • Description du dispositif
    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