Events

Retiro De Equipo (Recall) de Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-2016-RN-00283-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-15
  • 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-2016-RN-00283-2
  • 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
    Smith & nephew pty ltd. has identified a risk that some external power units have the potential to overheat and induce an electric shock whilst in use with the renasys go npwt pump. only certain external power units are affected by this issue. to date there have been 2 reported adverse events related to this issue, including one electric shock – discomfort, and one minor burn.
  • Acción
    Smith & Nephew is advising users to disconnect all affected power units from the mains electrical supply and switch to an unaffected power unit. The pump will continue to provide treatment as the device will run off its internal battery during this time. Affected units can be returned to Smith & Nephew and will be replaced with unaffected stock.

Device

Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wou...
  • Modelo / Serial
    Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System)Renasys GO External Power UnitPart Number: 66800161 Serial Numbers below 144500875ARTG Number: 155594
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd