Events

Retiro De Equipo (Recall) de SoKINOX NO (Nitric Oxide) Delivery and Monitoring System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-00851-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-12
  • 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-00851-1
  • 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
    Getinge has identified an issue where during no (nitric oxide) therapy, when a no cylinder runs nearly empty the system will indicate this by the "almost empty cylinder" icon. when the cylinder runs empty it will then trigger the alarm no cylinder 1 missing (or empty) or no cylinder 2 missing (or empty). this is indicated on the user interface by a crossed out cylinder icon. the system automatically shifts over to the other cylinder.Due to a pressure increase after the cylinder switch-over there are two possible issues identified:1. the cylinder status icon can change and erroneously indicate remaining gas in an empty no gas cylinder.2. the alarm “no cylinder 1 missing (or empty)” or “no cylinder 2 missing (or empty)” can be deactivatedif the empty no cylinder is not replaced, both no cylinders can run empty and cause a stop in no delivery. to date, there have been no reports of patient injury as a result of this issue.
  • Acción
    Getinge/Maquet will initiate an immediate update of all affected SoKINOX systems as soon as the system version 1.3 is released in Australia. Once version 1.3 available, customers will be contacted by a Getinge/Maquet sales or service representative to plan for the update of the device.

Device

SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
  • Modelo / Serial
    SoKINOX NO (Nitric Oxide) Delivery and Monitoring SystemDevice Number: 66 94 550ARTG Number: 273803
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA