Events

Retiro De Equipo (Recall) de Samaritan PDU 400 (automated external defibrillator)

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

¿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-2014-RN-00089-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-03
  • 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-2014-RN-00089-1
  • 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 software of samaritan pdu 400 devices may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning the user that the device has insufficient battery to deliver therapy the device may shut down. in such circumstances, an affected device may be unable to operate during a sudden cardiac arrest.This action was undertaken prior to the agreement of the communication by the tga.
  • Acción
    Areo Healthcare provided replacement PDU 400 devices to all affected customers.

Device

Samaritan PDU 400 (automated external defibrillator)
  • Modelo / Serial
    Samaritan PDU 400 (automated external defibrillator)Serial Numbers between 08P00001003 to 11P00007347
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare