# K092027: Carescape Monitor B850 - Pathway: 510(k) (Traditional) - Applicant: Ge Medical Systems Information Technologies - Decided: Aug 28, 2009 after 53 days - Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) - Device class: 2 - Regulation: 21 CFR 870.1025 - Recalls of this device: 9 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K000815 (2000). 11 ancestors in all. 38 later devices descend from it; 2 cite it directly. 1 of 50 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K071073: Solar 8000 and Transport Pro with Patient Data Module, Ge Medical Systems Information Technologies (2007) Summary page 1. - K051400: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or F-CU5(P) Monitor Frame Options, GE Healthcare (2006) Summary page 1. ## Most influential descendants - K102239: Carescape Monitor B650 (2010), 32 descendants of its own - K132533: Carescape Monitor B450 (2013), 14 descendants of its own - K131223: Carescape Monitor B650 (2013), 13 descendants of its own - K190008: Carescape One (2019), 11 descendants of its own - K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (2020), 10 descendants of its own ## Recalls of this device - May 4, 2015 · Class II · Z-1606-2015: The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the P - Jun 13, 2014 · Class II · Z-2085-2014: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may - Feb 28, 2014 · Class II · Z-1175-2014: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) a - Dec 27, 2013 · Class II · Z-0854-2014: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilatio - Dec 20, 2013 · Class II · Z-0927-2014: 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 m - Jul 20, 2012 · Class II · Z-1567-2013: GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication - Jul 20, 2011 · Class II · Z-2201-2013: GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM - Mar 8, 2011 · Not classified · Z-1929-2011: GE Healthcare has become aware of potential safety issues associated with the CARESCAPE" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PS - Jul 16, 2010 · Not classified · Z-2275-2010: GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential fo ## Indications for use 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. Source page: https://510kreport.com/device/K092027 Methodology: https://510kreport.com/methodology