Events

Avis De Sécurité sur Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par HILL ROM MODS.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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