Alerta De Seguridad para Liko Standard SlingBar 450

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Liko.

¿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
  • Fecha
    2013-05-20
  • Fecha de publicación del evento
    2013-05-20
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: liko standard slingbar 450 it has come to our attention that medical device manufacturer, liko, has initiated a field safety corrective action concerning standard slingbar 450. the affected product numbers are 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 or 5019013 (distributed between jan 1980 and nov 2012). the affected product numbers may be bundled with the golvo 1000, 3000, and 7000 series lifts, viking m, viking l, likolight 100 & 125, caroli 101, and uno 100, 101 & 102. the manufacturer has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver or bystander could result from tripping or otherwise falling into the sling bar, typically when the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder or groin. the manufacturer advises users to continue to follow safe lifting practices, and not to allow unauthorized persons, especially children, to play around or operate the lift. the current standard slingbar 450 model is designed in such a way that impalement may occur. liko has designed a safety cover to put on the top of the sling bar in order to reduce the risk of impalement. the manufacturer will provide affected customers modification kits. the customers will implement the correction themselves. where needed, a hill-rom technician or third party will complete the correction. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Liko Standard SlingBar 450
  • Manufacturer

Manufacturer