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-2018-RN-00058-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-16
  • 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-2018-RN-00058-1
  • 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
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the back plate of the self inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.
  • Acción
    Intersurgical is advising users to inspect stock and quarantine affected units for return. In instances where an alternative product is not available, Intersurgical is advising users to inspect each device before use to determine if it is affected by the issue. If the device is not affected, it can be safely used.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modelo / Serial
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsReference Number: 7150000, 7151000, 7152000, 7153000, 715400Lot Numbers: 7150000 – 372894, 7151000 – 372886, 7152000 – 372893, 7153000 – 372892, 7154000 – 370753 ARTG Number: 225855 (Intersurgical Australia Pty Ltd - Resuscitator, pulmonary, manual, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd