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.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

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.

Lote

Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR F1RF6114GR F1RF6118GR F1RF6123GR F1RF6130GR F1RF6227GR F1RF6236G F1RF6236GR F1RF6243GR F1RF6282GR F2G40578G F2G40579G F2G40580G F2G40581G F2G40584G F2G40585G F2G40586G F2G40588G F2G40592G F2G40593G F2G40594G F2G40595G F2G40596G F2G40598G F2G40599G F2G40605G F2G40606G F2G40607G F2G40609G F2G40610G F2G40611G F2G40615G F2G40631G F2G40705G F2G40820G F2G40835G F2RF3572G F2RF3640G F2RF3651G F3G45957G F3G45980G F3G46200G F43S0355G F43S0356G G0RF0516GR G0RF0592GR G0RF0596GR G1RF6518G G1RF6544G G1RF6546G G3G46241G G3G46616G G3G46649G G3G46664G G3G46674G G3G46679G H0RF0607GR H0RF0772G H0RF0845GR H2G41289G H2G41307G H2G41571GR H2G41786G H2G41787G H2RF4002GR J0RF0465G J0RF1103G J1RF7280G J1RF7281G J1RF7282G J1RF7283G J1RF7284G J1RF7285G J1RF7286G J1RF7289G J1RF7290G J1RF7298G J1RF7387G J2G42049G J2G42100GR J33T0400G J43S0499G J43S0503G J43S0504G J43S0506G J43T5719G J43T5720G J43T5727G J43T5731G J43T5799G J43T5801G J43T5810G J43T5812G J43T5813G J43T5814G J43T5815G J43T5827G J43T5831G J43T5832G J43T5877G J43T6078G K1RF7644G K1RF7673G K1RF7674G K1RF7675G K1RF7676G K1RF7678G K1RF7679G K1RF7680G K1RF7681G K1RF7683G K1RF7704G K1RF7925GR K33T0621G K33T1002G K43T6545G L1RF8243G L1RF8254G L1RF8255G L1RF8256G L1RF8258G L1RF8259G L1RF8261G L1RF8263G L1RF8264G L1RF8265G L1RF8267G L1RF8728G L1RF8733G L2G42609G L2G42643G L2G42666G L2G42668G L2G42669G L2G42690G L2G42711G L2G42970G L2RF4373GR L33T1324G M0RF2496G M0RF2562GR M1RF9841G M2G43248G M2RF4686G M33T1729G M33T2293G PA1786357 PA1786438 PA1786439 PA1786440 PA1786441 PA1786442 PA1786443 PA1786444 PA1786445 PA1786446 PA1786447 PA1786448 PA1786449 PA1786450 PA1786451 PA1786452 PA1786453 PA1786454 PA1786456 PA1786457 PA1786458 PA1786461 PA1786462 PA1786494 PA1786495 PA1786496 PA1786497 PA1786498 PA1786499 PA1786500 PA1786501 PA1786502 PA1786503 PA1786504 PA1786505 PA1786530 PA1786531 PA1786532 PA1786533 PA1786534 PA1786535 PA1786536 PA1786537 PA1786538 PA1786539 PA1786540 PA1786541 PA1786542 PA1786543 PA1786544 PA1786545 PA1786546 PA1786547 PA1786548 PA1786549 PA1786677 PA1786678 PA1786679 PA1786680 PA1786681 PA1786682 PA1786683 PA1786684 PA1786685 PA1786686 PA1786687 PA1786688 PA1786689 PA1786690 PA1786691 PA1786692 PA1786693 PA1786694 PA1786695 PA1786696 PA1786697 PA1786698 PA1786699 PA1786700 PA1786701 PA1786702 PA1786703 PA1786704 PA1786705 PA1786706 PA1786707 PA1786708 PA1786709 PA1786710 PA1786711 PA1786712 PA1786713 PA1786714 PA1786715 PA1786716 PA1787000 PA1787001 PA1787002 PA1787003 PA1787004 PA1787005 PA1787006 PA1787007 PA1787008 PA1787009 PA1787010 PA1787011 PA1787079 PA1787080 PA1787081 PA1787082 PA1787083 PA1787084 PA1787085 PA1787086 PA1787087 PA1787088 PA178

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States