Events

Retiro De Equipo (Recall) de Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)

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-2017-RN-01171-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-07
  • 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-01171-1
  • 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
    Philips has identified that st-segments in a 12-lead ecg may become distorted and the st-value may be inaccurate when an affected monitor automatically activates ecg filtering in the event that a “ecg check cable” or “ecg noisy elec xx” inop condition is triggered and displayed. these inops are triggered when the monitor detects a low impedance between ecg lead wires and the cable shield in the lead set, which can be caused by mechanical damage or fluid ingress.Distortions on the st-segment and associated numerics can contribute to a misdiagnosis or misinterpretation, which can cause a delayed or an incorrect treatment.
  • Acción
    Users are to complete and return the supplied acknowledgment form. Until the software is updated, users are to ensure that the “ECG Check Cable” or “ECG Noisy Elec xx” INOP is actioned following the instructions in the corresponding IFU. A Philips Healthcare representative will contact customers with affected devices to arrange a software update to correct the issue.

Device

Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (...
  • Modelo / Serial
    Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)Affected Products:IntelliVue Multi Measurement ServerProduct Number: M3001AIntelliVue Multi Measurement Server SLCPProduct Number: M3001ALIntelliVue Multi Measurement Server X2Product Number: M3002AIntelliVue MP2Product Number: M8102AIntelliVue MP5Product Number: M8105AARTG Numbers: 118076 and 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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