Events

Retiro De Equipo (Recall) de PAD 300/PAD 300P Public Access Defibrillators (PAD) (Semi-automated 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-2012-RN-00974-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-11-02
  • 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-2012-RN-00974-1
  • 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
    1.The device may turn itself on without input from the user. when this occurs, the normal sequence of audible prompts will be emitted from the device. if this issue continues undetected, the battery will eventually become completely depleted below the minimum battery capacity necessary to allow for the delivery of therapy.2. certain devices may misinterpret a temporary drop in battery voltage as signalling low battery. this issue will result in the device prematurely displaying the low battery warning and turning itself off even if sufficient battery capacity remains. if the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device will only deliver one shock before turning itself off. devices containing software version 1.4.2/ 3.2.0 or higher are not susceptible to this issue.
  • Acción
    Keep the devices in service. Follow the instructions from the sponsor to order a reserve battery pack and to download the new software. Aero Healthcare has advised the TGA that there are about 120 HeartSine PAD 300/PAD 300P units which could not be located during the recall. For more details, please see http://www.tga.gov.au/safety/alerts-device-heartsine-pad300-pad300p-131010.htm .

Device

PAD 300/PAD 300P Public Access Defibrillators (PAD) (Semi-automated defibrillator)
  • Modelo / Serial
    PAD 300/PAD 300P Public Access Defibrillators (PAD) (Semi-automated defibrillator)Affected serial numbers: 0400000501 to 0700032917, 08A00035000 to 10A0070753 & 10C00200000 to 10C00210318Manufactured between August 2004 and December 2010ARTG Number: 156690
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare