Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Recall
- Recall Number
- Z-0170-2019
- Event Number
- 81084
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- FEI Number
- 2221819
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 30, 2018
- Terminated
- December 20, 2018
- Address
- 800 Macarthur Blvd, Mahwah, NJ, 07430-2001
Description
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
The firm notified affected consignees on August 30, 2018, via Urgent Medical Device Recall letter. The letter advised customers of the software issue when more than 64 telemetry transmitters have been connected to a central station. Customers were advised to use the system normally, but informed that a Mindray Service Representative would be in contact to arrange for a system software update to be performed at the customer site. Mindrays Technical Support team may be reached at (877) 913-9663 (Option 1), Monday through Friday, 8:30am - 5:30pm ET should you have technical questions. Customers were also asked to complete and return an attached Acknowledgement and Receipt Form.
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
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