Events

Retiro De Equipo (Recall) de Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)

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

¿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-01185-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-11
  • 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-01185-1
  • 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
    Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. the top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. the consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the us fda, 3 serious injuries occurred (2 broken bones and 1 laceration).
  • Acción
    Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction. For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-system

Device

Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)
  • Modelo / Serial
    Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)Model: C300 Corpus IISerial Numbers: 2537002437, 2537002471, 2537002476, 2537002514, 2537002746, 2537002891 and 2537002956Model: C350 Corpus IISerial Number: 43203511Model: C500 Corpus IISerial Number: 15702655 Model: C500 Corpus II LRSerial Numbers: 2557000160 and 2557000185ARTG Number: 224603
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia