Events

Retiro De Equipo (Recall) de LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Physio-Control 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-2017-RN-01389-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-11-08
  • 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-2017-RN-01389-1
  • 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
    Physio-control is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by cardinal health, does not meet physio-control’s specifications, and shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. if the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. this may result in failure to defibrillate and serious injury or death. there have been no reports of injuries associated with this issue.
  • Acción
    Users are advised to inspect the "Electrode pouch and box labelling" and the "Electrode Starter Kit box labelling" to determine if the electrodes are affected. Users are advised to place of copy of the correct electrode packaging and labelling with each affected AED, until the electrodes have been replaced by Physio- Control.

Device

LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED...
  • Modelo / Serial
    LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connectorElectrodeCatalogue Number: 111401-000016MIN: 3202380-006Lot Numbers: 713609, 717912, 713904, 718033, 715008 and 719323Electrode Start KitsCatalogue Number: 11101-000017MIN: 3202784-009Lot Numbers: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823 and 46078012ARTG Number: 232970
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA