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.
Enforcement
- Recall Number
- Z-0630-2013
- Event ID
- 63616
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 9, 2013
- Initiation Date
- May 12, 2011
- Classification Date
- January 3, 2013
- Termination Date
- February 19, 2013
- Address
- 800 MacArthur Blvd., N/A, Mahwah, NJ, 07430, United States
Description
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.
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.
510 K K080192 P/N 300BF-PA200002
Nationwide Distribution including OH and GA
two units