Events

Rappel de Device Recall CARESCAPE Monitor B850

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66946
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0927-2014
  • Date de mise en oeuvre de l'événement
    2013-12-20
  • Date de publication de l'événement
    2014-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124273
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA