GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: 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 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
Recall
- Recall Number
- Z-0096-2019
- Event Number
- 81075
- Firm
- GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland
- FEI Number
- 3002806783
- Product Code
- DQK
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 4, 2018
Description
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: 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 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
The firm issued the Medical Device Correction Notice on 09/04/2018 by letter. The letter explained the issue and provided the following safety instructions: If a prolonged network overload occurs and CARESCAPE Monitor Bx50 on the network does not resume normal functionality in approximately 90 seconds, take the following actions: 1. Temporarily switch the monitor from central monitoring to local-only (bedside) monitoring: - Disconnect the LAN cables from IX/MC ports on backside of the monitor. The monitor will now be in local-only mode. - Keep the patient under close observation and continuous surveillance at the local (bedside) monitor. 2. Contact your IT department or other appropriate personnel in your facility responsible for the Patient Monitoring Network, and provide them with the further instructions on network configuration. 3. After the network issue has been resolved, switch the monitor back into central monitoring by re-connecting the LAN cables to IX/MC ports. 4. Verify correct monitoring state and alarm function. If a transient network overload occurs in which the CARESCAPE Monitor Bx50 on the network restarts within approximately 90 seconds (i.e., all functionality resumes and the monitor reconnects to the network automatically), proceed with instruction step #2 above to check network functionality.
Worldwide Distribution-US Nationwide
47,937 units