Events

Retiro De Equipo (Recall) de Hill-Rom MC700 General Ward Bed

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hill-Rom Pty Ltd.

¿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
    RC-2014-RN-00537-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00537-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Hill-rom has found that some of the hill-rom mc700 general ward beds, manufactured between the dates specified, may experience problems with the brakes; if the brake system is not fully engaged upon activation, the brakes may become disengaged when the bed is shaken. this can result in unwanted bed movement, and possible patient or caregiver injury.
  • Acción
    Hill-Rom is advising their customers to ensure that beds are monitored for brake malfunction. If a brake malfunction is observed remove the bed from service. Hill-Rom is currently working on a long term correction which will be installed on all affectd beds once complete. This action has been closed-out on 17/08/2016.

Device

Hill-Rom MC700 General Ward Bed
  • Modelo / Serial
    Hill-Rom MC700 General Ward BedSerial Numbers: 006505 to 009144Manufactured from Jan 2012 to Feb 2014ARTG Number: 170974
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd