Retiro De Equipo (Recall) de Device Recall GE 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
    57288
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1929-2011
  • Fecha de inicio del evento
    2011-03-08
  • Fecha de publicación del evento
    2011-04-08
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Ge healthcare has become aware of potential safety issues associated with the carescape" monitor b850 when patient data module (pdm), tram acquisition module (tram), patient side module (e-psm or e-psmp), e- masimo or e-(p)re(s)tn modules or bed-to-bed alarming feature is used. 1. when carescape monitor b850 is used with the above listed modules, some spo2 alarms may be delayed or missed. 2. whe.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the recall product the problem, Safety Issues, Affected Product details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to follow the safety instructions provided in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available. If you have any questions regarding this medical device correction or the identification or affected items please contact Technical Support at 1-800-558-7044, or your local Service Representative.

Device

  • Modelo / Serial
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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of:AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA,WA, WI, and WV; and countries including: JERUSALEM, UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, QATAR, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLAND, MALTA, MALAYSIA, LEBANON, KUWAIT, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CHILE , CANADA, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA.
  • Descripción del producto
    GE || The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options. The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure. || The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SpO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 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. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
  • Manufacturer

Manufacturer

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