Events

Retiro De Equipo (Recall) de Flex Cardio Patient Monitoring System

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 Invivo 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
    78465
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0082-2018
  • Fecha de inicio del evento
    2017-08-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159623
  • 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(without arrhythmia detection or alarms) - Product Code MWI
  • Causa
    Intermittent communication between the host system and the flex cardio.
  • Acción
    On August 2017 the firm sent letters to their consignees indicating the following: This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. ------------------------------------------- A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur: " Inability of the Flex Cardio to connect to the host system. " Boom Monitor (display) may not display all active waveform and/or vital sign data. " Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor. " After patient admission and case initiation at the host system, the case may not be fully transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will display vital sign data, but the Flex Cardio will not provide audible alarms. " After patient discharge and case termination at the host system, case termination may not be transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will continue to display vital sign data, and the Flex Cardio will continue to provide audible alarms. Our re

Device

Flex Cardio Patient Monitoring System
  • Modelo / Serial
    Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.
  • Descripción del producto
    Xper Flex Cardio PhysioMonitoring system || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Dirección del fabricante
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA