Events

Retiro De Equipo (Recall) de Device Recall Philips IntelliVue MX4O WLAN Patient Wearable Monitor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Electronics North America Corporation.

¿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
    76656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1707-2017
  • Fecha de inicio del evento
    2017-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153762
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    Philips lntellivue mx4o wlan patient wearable monitor may not automatically switch to monitor mode with audible alarms when association with central monitoring system is unsuccessful [incomplete].
  • Acción
    Philips issued Field Safety Notice on 3/6/17. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer .Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: When a No Data Tele INOP alert is displayed on a Philips IntelliVue Information Center iX (PIIC iX), check the MX40 as directed in the PIIC iX B.01 IFU, page 87. If the MX40 is in the Coverage Area, remove the battery, and reinsert the battery. If the MX40 is not in the Coverage Area, 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. Philips is releasing a software upgrade B.06.18 for affected Philips IntelliVue MX40 Patient Wearable Monitors. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade

Device

Device Recall Philips IntelliVue MX4O WLAN Patient Wearable Monitor
  • Modelo / Serial
    The following product number and Exchange part numbers containing the combination of HW Revision C.01 .01 with SW Revisions B.05 or B.06 of the Philips IntelliVue MX4O Patient Wearable Monitor
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kingdom
  • Descripción del producto
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor || Product: 865352 || Exchange part (service numbers): || 453564615311 TELE PWM,802.lla/b/g,ECG only, US only || 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02;, US only || Product Usage: || Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA