Device product
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
Z-1611-2014
Product summary
- Event
- Event 67932
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1611-2014
Official wording
Reason: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Code information: monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
Distribution pattern: US Nationwide Distribution in the state of OH
Derived failure modes
-
Unknown
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.