InjuryGYE
NIHON KOHDEN
Received Aug 17, 2009 · Event occurred Jul 17, 2009
Report MW5012480 · MDR key 1444483
Device
Product problems
- Incorrect Software Programming Calculations
Patient
43 YR
- No Information
Narrative
Description of Event or Problem
MONITOR REPORTS CALCULATED MAP THAT DIFFERS FROM MANUALLY CALCULATED MAP OR NATIVE AVERAGE OF SYS AND DIASTOLIC PRESSURES. IN THIS CASE, HYPERTENSIVE ENCEPHALOPATHY, THE TARGET MAP FOR BP REDUCTION DIFFERED BY APPROXIMATELY 30 MM HG LEADING TO CONFUSION OVER WHICH TARGET SHOULD BE USED, WHICH VALUE USED FOR MONITORING, ETC. DEVICE DOES NOT INFORM USER OF THE DISCREPANCY, THE REASON FOR IT, WHICH VALUES SHOULD BE USED TO GUIDE THERAPY - EG, MANUALLY CALCULATED OR AUTOMATICALLY DISPLAYED.