Events

Retiro De Equipo (Recall) de Device Recall CARESCAPE Monitor B850

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 GE Healthcare, LLC.

¿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
    66946
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0927-2014
  • Fecha de inicio del evento
    2013-12-20
  • Fecha de publicación del evento
    2014-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124273
  • 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
    There is a potential for communication loss associated with the f5-01 frame when connected to carescape patient data module (pdm) in the carescape monitor b850. the pdm patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the f5-01 frame due to an issue with the pdm ethernet communication hardware. the communicatio.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated December 20, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter addressed the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Call Technical Support at 1-800-558-7044 or your local Service Representative).

Device

Device Recall CARESCAPE Monitor B850
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AZ, AR, CA, CO, CT, FL,GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA,PR, SC, TN,TX, UT, VA, WA, WV, WI. UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SWITZERLAND, SWEDEN SLOVENIA, SLOVAKIA, SPAIN, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NORWAY, NORTH KOREA, NEW ZEALAND, NETHERLANDS, MALTA, MALAYSIA, LITHUANIA, LEBANON, KUWAIT, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, DENMARK, ESTONIA, CZECH REPUBLIC, BELGIUM BAHRAIN, COLOMBIA, CHILE CANADA, BRAZIL, AUSTRIA, AUSTRALIA.
  • Descripción del producto
    GE Healthcare, CARESCAPE Monitor B850 || The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, EGG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA