Events

Retiro De Equipo (Recall) de Philips HeartStart XL+ Defibrillator/Monitor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2014-RN-00112-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-04
  • 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-00112-1
  • 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 philips heartstart xl+ defibrillator/monitor battery may take slightly longer to charge to 100% at 35 deg c than specified in the instructions for use (ifu).
  • Acción
    Philips is providing users with an addendum to the Instructions for Use (IFU) specifying the battery charge time and temperature specifications. The addendum specifies the proper battery charge time with the device turned off and PC power connectors i.e., with temperature at 25 deg C (77 deg F), it will take less than 3 hours to charge at100% capacity and less than 2 hours to charge at 80% capacity.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Modelo / Serial
    Philips HeartStart XL+ Defibrillator/Monitor Model number 861290Multiple Serial Numbers affectedARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA