Events

Retiro De Equipo (Recall) de Device Recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (P

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 Medical Systems, Inc..

¿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
    68349
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1746-2014
  • Fecha de inicio del evento
    2014-05-22
  • Fecha de publicación del evento
    2014-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127391
  • 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
    Monitor,physiological,patient (with arrhythmia detection or alarms - Product Code MHX
  • Causa
    Intellivue mx40 (part numbers 865350, 865352) with software revisions b.00 or b.01 may not resume alarming when the alarms are paused and the pause timer ends.
  • Acción
    On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a free of charge software upgrade. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: The following two items must be configured when using MX40 with the IntelliVue Information Center iX: 1. Utilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms Utilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device

Device

Device Recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Inform...
  • Modelo / Serial
    Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
  • Descripción del producto
    IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA