Events

Retiro De Equipo (Recall) de Philips IntelliVue MX40 WLAN Patient Wearable 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-2017-RN-00431-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-04
  • 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-00431-1
  • 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
    An issue has been discovered that under specific 802.11 network conditions, a partial re-association of the mx40 wlan monitor to a compatible central monitoring system (“information center”) is possible. in this state, although the information center provides a visible and audible “no data tele” inop alert, the mx40 wlan itself enters telemetry mode, ie. its screen turns off in one minute and local alarming is disabled. if this issue were to occur while monitoring a patient, it could result in a delay in treatment. to date, phillips has received no complaints involving clinical use that could be associated with this issue.(please note that this issue only involves mx40 wlan monitors, i.E. those operating on a customer-provided 802.11 wireless lan. mx40 monitors with 1.4 ghz and 2.4 ghz smart-hopping radios are not affected).
  • Acción
    In the event that, a “No Data Tele” INOP alert is displayed on a Philips IntelliVue Information Center iX (“PIIC iX”), Philips is advising users to check the MX40 as directed in the PIIC iX B.01 IFU (page 87). Users are further advised that if the MX40 is in the Coverage Area, to remove and reinsert the battery. However, if the MX40 is not in the Coverage Area, users are requested to place the sector in the PIIC iX in “standby” as directed in the MX40 B.06 IFU (page 53) or return the patient and MX40 to the Coverage Area. As a permanent solution, Philips is releasing a software upgrade B.06.18 for affected devices and users are advised that a Philips representative will contact affected customers to arrange for the installation of the software upgrade.

Device

Philips IntelliVue MX40 WLAN Patient Wearable Monitor
  • Modelo / Serial
    Philips IntelliVue MX40 WLAN Patient Wearable MonitorProduct Number: 865352Exchange Part (Service Numbers): 453564615351 TELE PWM,802.11a/b/g,ECG only, ex, non-US453564615371 TELE PWM,802.11a/b/g,ECG&Sp02;, ex, non-USARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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