Events

Notificaciones De Seguridad De Campo acerca de Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and Masterlift® Systems

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.

¿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
    Corrosion on ceiling mounted overhead lift rail system installations in indoor swimming pool areas this field safety notice relates to fasteners securing overhead lift rail systems to ceilings in highly chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. to date, this has been reported to hill-rom twice with over 85,000 installations worldwide. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the hardware. scc is a type of localized corrosion characterized by fine cracks which can propagate rapidly leading to failure of the components. scc may occur in the presence of highly chlorinated environments such as swimming pool areas. there is a small risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders. .

Device

Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and M...

Manufacturer

Hill-Rom