Recall – Distributed Monitoring System (DMS)

Company: Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report 10/24/2018
Class II:

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

Recall Number: Z-0170-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ on 8/30/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5

DISTRIBUTION
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

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