Events

Rappel de Device Recall GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors

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
    58489
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3075-2011
  • Date de mise en oeuvre de l'événement
    2011-07-05
  • Date de publication de l'événement
    2011-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99459
  • 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
    Ge healthcare has recently become aware of an issue with the dash 3000/4000/5000 patient monitors configured with the 802.11b wireless lan option that may impact patient safety. the dash monitor may exhibit reboots on some networks when the 802.11b wireless lan option is used to connect to the hospital wireless lan infrastructure. this reboot results in a loss of patient monitoring for approxima.
  • Action
    GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. GE recommended actions that should be taken by a qualified service representative. For any questions regarding the medical device correction or identification of affected items contact Technical Support at 1-800-558-7044 or customers should contact their local Service Representative. UPDATE: A second letter dated 12/13/11 was sent on 1/20/12 to consignees. The revised letter provides an update to the safety instructions and product correction.

Device

Device Recall GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI and the countries of UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVENIA, SINGAPORE, SAUDI A ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, KUWAIT, JAPAN, ITALY, ISRAEL, INDIA, GERMANY, FRANCE, FINLAND, ESTONIA, ECUADOR, DENMARK, CANDA, BELGIUM AUSTRIA, AUSTRALIA, and ALGERIA.
  • Description du dispositif
    GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors || The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
  • 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