Events

Retiro De Equipo (Recall) de Device Recall DPM Central Station

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 Mindray DS USA, Inc. d.b.a. Mindray North America.

¿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
    63616
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0630-2013
  • Fecha de inicio del evento
    2011-05-12
  • Fecha de publicación del evento
    2013-01-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114367
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Causa
    There is a software anomaly with the dpm central monitoring system where the trend data of one patient maybe replaced with the trend data of a second patient.
  • Acción
    Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121.

Device

Device Recall DPM Central Station
  • Modelo / Serial
    510 K K080192 P/N 300BF-PA200002
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including OH and GA
  • Descripción del producto
    DPM Central Station || Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 || The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
  • Manufacturer
    Mindray DS USA, Inc. d.b.a. Mindray North America

Manufacturer

Mindray DS USA, Inc. d.b.a. Mindray North America