PlainRecalls
FDA Devices Moderate Class II Terminated

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Reported: October 24, 2018 Initiated: August 30, 2018 #Z-0170-2019

Product Description

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Reason for Recall

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.

Details

Units Affected
5
Distribution
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled? ▼
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00. Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 5.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0170-2019.

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