Events

Retiro De Equipo (Recall) de BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Intersurgical Australia 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-00736-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-20
  • 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-00736-1
  • 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
    Intersurgical has identified the possibility that the valve of the bvm manual resuscitation system may become stuck during storage. this could result in theintended tidal volume not being delivered through the valve, which may cause a delay in treatment.The instructions for use (ifu) provided with these products includes the requirement to ensure that the bag, valve and oxygen delivery are functioning correctly prior to use.
  • Acción
    Users are asked to inspect their stocks and quarantine all units from the above lot numbers, then complete the attached Reply Form and email or fax it to us so that we may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile this process.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modelo / Serial
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsMultiple Reference and Lot NumbersARTG Number: 225855
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd