Device product
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
Z-0630-2013
Product summary
- Event
- Event 63616
- Status
- Terminated
- Classification
- Class II
- Quantity
- two units
- Official record key
device-enforcement:Z-0630-2013
Official wording
Reason: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Code information: 510 K K080192 P/N 300BF-PA200002
Distribution pattern: Nationwide Distribution including OH and GA
Derived failure modes
-
Device software or design
software anomaly