GE Healthcare CARESCAPE Monitor B650
Recall
- Recall Number
- Z-2340-2018
- Event Number
- 80262
- Firm
- GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland
- FEI Number
- 3002806783
- Product Code
- DQK
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- May 25, 2018
Description
GE Healthcare CARESCAPE Monitor B650
When multiple CARESCAPE Monitor B650 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 notified its consignees of the problem by letter on 05/25/2018. The letter stated the following safety instructions: "If a prolonged network overload occurs and CARESCAPE Monitor B650 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. Disconnect used LAN cables from the monitor, see Figure 1, below, showing the cables to disconnect. 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 provided. 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 B650 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. If your network is not maintained by GE, please ensure that the network in your facility meets the network configuration requirements. GE Healthcare will provide revised network installation and user instructions documentation at no cost to you. Complete and return the Customer Response Form attached to this notification. Once the Customer Response Form is received, GE Healthcare will arrange for the documentation delivery. " NOTE: The letter has an attachment, "Appendix A", which has more detail on the net work configuration.
worldwide
69231 units