Events

Retiro De Equipo (Recall) de Hercules Patient Lifter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por R & R Healthcare Equipment 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-2017-RN-01492-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-08
  • 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-2017-RN-01492-1
  • 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
    R&r; healthcare identified that the hercules patient lifter, the spreader bar (which holds the sling) is secured to the lifter arm by a lock tighten dome nut. there has been one report of this dome nut becoming loose causing the spreader to detach from the lifter arm, resulting in a client fall.
  • Acción
    R & R Healthcare is advising distributors to inspect stock and ensure the dome nut is tight. A repair kit will be provided for all lifts to be inspected. Users are advised check that the dome nut is tight, and the spreader bar is secured to the lifter arm. The supplier of the lift will be installing an additional locking pin to the lifter.

Device

Hercules Patient Lifter
  • Modelo / Serial
    Hercules Patient Lifter Model Number: H150MTSerial Numbers: 2015 07 LFT 005T 001 to 2015 07 LFT 005T 079 and 2015 39 LFT 005T 040 to 2015 39 LFT 005T 066ARTG Number: 224479
  • Manufacturer
    R & R Healthcare Equipment Pty Ltd

Manufacturer

R & R Healthcare Equipment Pty Ltd