Device Recall GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    67430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1147-2014
  • 사례 시작날짜
    2014-02-13
  • 사례 출판 날짜
    2014-03-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Ge healthcare has recently become aware of a potential safety issue with the solar 8000m/i patient monitor automatic-view-on-alarm (avoa) feature. the solar 8000m/i avoa feature will stop functioning if the patient monitor is discharged from the cic central station while a remote automatic bedside alarm view is currently being displayed on the solar. once this issue occurs, subsequent remote av.
  • 조치
    GE Healthcare sent a "Urgent Medical Device Correction" letter dated February 12, 2014. The letter was sent to all affected customers. It identified the product the problem and the action needed to be taken by the customers. This issue affects all Solar 8000M/i Patient Monitors running software version 5.4, 5.5, or 5.6 with the Automatic-View-On-Alarm (AVOA) feature enabled. GE Healthcare will provide a correction at no charge once it is available. We will contact you to arrange for this correction. Please contact Technical Support at 1-800-558-7044 or your local Service Representative.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, NS, NO, NE, NH, NH, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and WY., and the countries of : AUSTRALIA, CANADA, AUSTRIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, CHINA, COSTA RICA, CYPRUS, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, JAPAN, MALAYSIA, MEXICO, NAMBIA, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, SERBIA AND YUGOSLAVIA.
  • 제품 설명
    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. || The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module 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 medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA