Events

Retiro De Equipo (Recall) de Samaritan PAD 500P (Public Access 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-00243-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-03
  • 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-00243-1
  • 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 in the affected samaritan® pad 500p may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level.
  • Acción
    Aero Healthcare is advising users not to remove devices from service. Aero Healthcare is advising users that to address the issue an updated software version is available on the HeartSine Technologies website for download. Please follow the instructions provided by Aero Healthcare to download the new software. Alternatively, Aero Healthcare can provide an upgrade kit which includes a CD with the updated software version.

Device

Samaritan PAD 500P (Public Access Defibrillator)
  • Modelo / Serial
    Samaritan PAD 500P (Public Access Defibrillator) Serial Numbers: 10B0010001 to 14B00461703Manufactured between February 2010 and January 2014ARTG Number: 156690
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare