Events

Retiro De Equipo (Recall) de Hill-Rom Affinity 4 Birthing Bed

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Hill-Rom Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    16973
  • Fecha de inicio del evento
    2014-07-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Causa
    Hill-rom would like to remind users of proper handling of the lift-off foot section per the affinity four birthing bed manual. improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. if the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. if the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
  • Acción
    Product to be modified

Device

Hill-Rom Affinity 4 Birthing Bed
  • Modelo / Serial
    Model: Part Number: P3700B/C/D/E, Affected: Manfactured between Oct-2006 and Jun-2014
  • Manufacturer
    Hill-Rom Inc

Manufacturer

Hill-Rom Inc