MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-17 for NIHON KOHDEN BSMS-2345A * manufactured by *.
[22125612]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012480 |
| MDR Report Key | 1444483 |
| Date Received | 2009-08-17 |
| Date of Report | 2009-08-17 |
| Date of Event | 2009-07-17 |
| Date Added to Maude | 2009-08-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIHON KOHDEN |
| Generic Name | NONE |
| Product Code | GYE |
| Date Received | 2009-08-17 |
| Model Number | BSMS-2345A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2009-08-17 |