Events

Retiro De Equipo (Recall) de IntelliVie Information Centre (PIIC) iX (centralised patient 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-2015-RN-01226-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-16
  • 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-01226-1
  • 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
    Calculated ecg leads, also referred to as reconstructed leads when viewed or printed at the information center ix, may misrepresent the ecg waveform morphology in some reconstructed leads. (the full set of six limb leads is commonly calculated from 2 limb leads.)following are the lead combinations that are affected.· lead i and lead iii-(avl incorrectly reconstructed)· lead i and lead avr-(avl lead incorrectly reconstructed)· lead iii and lead avf-(ii incorrectly reconstructed)with this combination and hexad on, the 4 derived v leads morphology will also be misrepresented in review applications.Trx/mx40 only – iii, v or avr, v (avl incorrectly reconstructed) review applications only.
  • Acción
    Philips will be providing a software upgrade as a permanent correction. In the interm, users are informed that: - Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. - The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. Users are also advised that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

Device

IntelliVie Information Centre (PIIC) iX (centralised patient monitor)
  • Modelo / Serial
    IntelliVie Information Centre (PIIC) iX (centralised patient monitor)Affected Systems:866023 IntelliVue Information Centre iX, A.0866389 IntelliVue Information Centre iX, B.0866117 PIIC Classic UpgradeARTG Number: 94237
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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