GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital 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 ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O 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. 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 SvO2 (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.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Nationwide Distribution including DC and PR, except DE, SD, ND, and VT. OUS: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.

Lote

Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED13027435GA 2020913-002 SED13027444GA 2020913-002 SEW11456764HA M1176021-094955 SEW11487296HA M1176021-094955 SEW11487300HA M1176021-094955 SEW11487304HA M1176021-094955 SEW11487306HA M1176021-094955 SEW11487307HA M1176021-094955 SEW11487308HA M1176021-094955 SEW11487309HA M1176021-094955 SEW11487310HA M1176021-094955 SEW11487312HA M1176021-094955 SEW11487313HA M1176021-094955 SEW11487314HA M1176021-094955 SEW11487315HA M1176021-094955 SEW11487316HA M1176021-094955 SEW11487317HA M1176021-094955 SEW11497510HA M1176021-094955 SEW11497511HA M1176021-094955 SEW11497512HA M1176021-094955 SEW11497513HA M1176021-094955 SEW11497514HA M1176021-094955 SEW11497515HA M1176021-094955 SEW11497517HA M1176021-094955 SEW11497518HA M1176021-094955 SEW11497519HA M1176021-094955 SEW11497532HA M1176021-094955 SEW11497534HA M1176021-094955 SEW11497535HA M1176021-094955 SEW11497536HA M1176021-094955 SEW11497537HA M1176021-094955 SEW11497538HA M1176021-094955 SEW11497539HA M1176021-094955 SEW11497540HA M1176021-094955 SEW11497555HA M1176021-094955 SEW11497556HA M1176021-094955 SEW11497557HA M1176021-094955 SEW11497558HA M1176021-094955 SEW11497560HA M1176021-094955 SEW11497581HA M1176021-094955 SEW11497583HA M1176021-094955 SEW11497584HA M1176021-094955 SEW11497585HA M1176021-094955 SEW12049003HA M1176021-100869 SEW12059331HA M1176021-100713 SEW12316595HA M1176021-120906 SEW12316596HA M1176021-120906 SEW12357363HA M1176021-120906 SEW12357365HA M1176021-120906 SEW12357366HA M1176021-120906 SEW12357368HA M1176021-120906 SEW12357485HA M1176021-120906 SEW12357488HA M1176021-120906 SEW12357489HA M1176021-120906 SEW12357490HA M1176021-120906 SEW13068518HA M1176021-094955 SEW13193084HA M1176021-186679 SEW13193101HA M1176021-186640 SEW13193102HA M1176021-186640 SEW13203400HA M1176021-186640 SEW13244941HA M1176021-187302 SED11168563GA 2020913-002 SED12526653GA 2020913-003 SED12526658GA 2020913-003 SED12526659GA 2020913-003 SED12526672GA 2020913-003 SED13006700GA 2020913-003 SED13006701GA 2020913-003 SED13006702GA 2020913-003 SED13006737GA 2020913-003 SED13006738GA 2020913-003 SED13016768GA 2020913-003 SED13016769GA 2020913-003 SED13016775GA 2020913-003 SED13016813GA 2020913-003 SED13158803GA 2020913-002 SED13158809GA 2020913-002 SED13158919GA 2020913-002 SED13168985GA 2020913-002 SED13168986GA 2020913-002 SED13168987GA 2020913-002 SED13168988GA 2020913-002 SED13168989GA 2020913-002 SED13168990GA 2020913-002 SED13168991GA 2020913-002 SED13168992GA 2020913-002 SED13168993GA 2020913-002 SED13168994GA 2020913-002 SED13168995GA 2020913-002 SED13168996GA 2020913-002 SED13168997GA 2020913-002 SED13168999GA 2020913-002 SED13169000GA 2020913-002 SED13169001GA 2020913-002 SED13169002GA 2020913-002 SED13169003GA 2020913-002 SED13169004GA 2020913-002 SED13169005GA 2020913-002 SED13169007GA 2020913-002 SED13169008GA 2020913-002 SED13169009GA 2020913-002 SED13169010GA 2020913-002 SED13169011GA 2020913-002 SED13169012GA 2020913-002 SED13169013GA 2020913-002 SED13169014GA 2020913-002 SED13169045GA 2020913-002 SED13169046GA 2020913-002 SED13169050GA 2020913-002 SED13169055GA 2020913-002 SED13169056GA 2020913-002 SED13169057GA 2020913-002 SED13169059GA 2020913-002 SED13169060GA 2020913-002 SED13169061GA 2020913-002 SED13169062GA 2020913-002 SED13169063GA 2020913-002 SED13169064GA 2020913-002 SED13169070GA 2020913-002 SED13169087GA 2020913-002 SED13169093GA 2020913-002 SED13169116GA 2020913-002 SED13169120GA 2020913-002 SED13169125GA 2020913-002 SED13169126GA 2020913-002 SED13169127GA 2020913-002 SED13169129GA 2020913-002 SED13169131GA 2020913-002 SED13169132GA 2020913-002 SED13169135GA 2020913-002 SED13169141GA 2020913-002 SED13179229GA 2020913-002 SED13189379GA 2020913-002 SED13189380GA 2020913-002 SED13189470GA 2020913-002 SED1318

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States