Events

Retiro De Equipo (Recall) de HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)

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-00655-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-06-18
  • 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-00655-1
  • 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
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • Acción
    Aero Healthcare is advising that all the affected units are within the control of the distributors. The distributors are advised that the affected units should be placed in quarantine to await collection by Aero Healthcare.

Device

HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation ele...
  • Modelo / Serial
    HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)Lot Numbers: A1754, A1795, A1792, A1789, A1802 ARTG Numbers: 161839 (Adult Pad-Pak) and 161841 (Paediatric Pedi-Pak)
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare