Events

Retiro De Equipo (Recall) de Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Proact Medical Systems (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-2015-RN-00707-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-06
  • 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-00707-1
  • 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 internal review, philips identified that it was not explicitly described in the instructions for use that the o2 test must be done as part of the daily check to ensure that the machine measures the o2 concentration in the fresh gas correctly, and can deliver the desired o2 concentration in the fresh gas to the patient.Incorrect measurement of o2 concentration in the fresh gas or o2 concentration in the fresh gas not at desired level, can potentially cause hypoxia to the patient.
  • Acción
    Review the Recall for Product Correction and the update to the IFU and ensure that the changes are understood and that all personnel using the device are informed about the content in this Recall for Product Correction. This action has been closed-out on 17/08/2016.

Device

Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550...
  • Modelo / Serial
    Siesta i TS machine(P/N # 866163/10653-00) with a serial number within the following range:200550022 to 200949001AM5153237 to AM5156683DK25100001 to DK43000256ARTG Number: 176848
  • Manufacturer
    Proact Medical Systems (Australia) Pty Ltd

Manufacturer

Proact Medical Systems (Australia) Pty Ltd