Events

Retiro De Equipo (Recall) de Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fastening

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Active Medical Supplies 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-00522-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-26
  • 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-00522-1
  • 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
    The manufacturer nortec medical have advised that the keyhole clips on pivot, pivot hygiene, pivot hammock and tony pringle clip style sling may break. there have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component which is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot.If the clip on the sling were to fail under load (whilst a patient is being transferred), the patient will fall from the hoist.
  • Acción
    Active Medical requests that all recalled sling/s must be removed from service and disposed of. Users are requested to return a completed Urgent Medical Device Recall Notification form (provided with the Customer letter) and return it to Active Medical Supplies at recalls@activemedicalsupplies.com.au or fax to (07) 3899 8825 or post to Active Medical Supplies – Quality Assurance PO BOX 3392 TINGALPA QLD 4173. Replacement slings will be made available to affected customers.

Device

Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip faste...
  • Modelo / Serial
    Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fasteningARTG Number: 146792
  • Manufacturer
    Active Medical Supplies Pty Ltd

Manufacturer

Active Medical Supplies Pty Ltd