Events

Retiro De Equipo (Recall) de Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)

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-2015-RN-00425-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-18
  • 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-2015-RN-00425-1
  • 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
    Recent revisions of the device’s instructions for use (ifu) (part number 989803162691, rev. f- rev. h) inaccurately indicates that one of the temperature probe’s application sites is “endotracheal”. the application site should be listed as“esophageal”. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised.
  • Acción
    Philips is providing the customers with an errata sheet to the Expression IFU, which removes endotracheal as an application site. Philips is working on a solution to this issue and once a solution is available, Philips will provide the customers with another communication outlining the plans for implementing the solution. This action has been closed-out on 24/08/2016.

Device

Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI ...
  • Modelo / Serial
    Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)Product Code: 865214 (In vivo Expression MRI Patient Monitoring System)Serial Numbers: US31204924, US31205148, US31205180, US42707074, US42707166, US42707375, US42707396ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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