Events

Retiro De Equipo (Recall) de Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96

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-2016-RN-00090-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-20
  • 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-2016-RN-00090-1
  • 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
    The st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the following host monitor configuration:st analysis: “off” ste: “on“ste alarms: “on”the problem only occurs if either of the affected philips intellivue measurement modules are used with philips intellivue patient monitors with hexad option #c54 (also bundled in options h11, h41, h42, cp2), or if an affected x2 measurement module is used in standalone mode (i.E., not connected to another monitor).There is potential for delay in diagnosis due to the monitor not alarming for st elevation on the chest leads.
  • Acción
    Philips Healthcare is advising users to ensure the ST Analysis is switched to ON when using STE measurement. A software upgrade will be installed as a permanent correction.

Device

Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versio...
  • Modelo / Serial
    Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96Affected Philips IntelliVue Measurement Modules:Model Number: X1Product Number: M3001A Software Revision: K.21.54 or L.00.96Model Number: X2Product Number: M3002A Software Revision: K.21.54 or L.00.96 ARTG Number: 94238
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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