MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-05 for (QS) COROMETRICS/GE MEDICAL Q.S. (QUANTITATIVE SENTINE) (COMPUTER SW) manufactured by G.e. Medical Systems, Info Tech Systems.
[209229]
During labor, monitor alarm was manually deactivated. Upon an event of a decreasing fhr, alarm did not sound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 361235 |
| MDR Report Key | 361235 |
| Date Received | 2001-11-05 |
| Date of Report | 2001-11-02 |
| Date of Event | 2001-10-18 |
| Date Facility Aware | 2001-10-22 |
| Report Date | 2001-11-02 |
| Date Added to Maude | 2001-11-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | (QS) COROMETRICS/GE MEDICAL |
| Generic Name | FETAL MONITORING SURVEILLANCE AND CHARTING |
| Product Code | KXN |
| Date Received | 2001-11-05 |
| Model Number | Q.S. (QUANTITATIVE SENTINE) |
| Catalog Number | (COMPUTER SW) |
| Lot Number | * |
| ID Number | SOFTWARE VERSION 5.05.3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 350389 |
| Manufacturer | G.E. MEDICAL SYSTEMS, INFO TECH SYSTEMS |
| Manufacturer Address | 200 HARR S. TRUMAN PKWY SUITE 220 ANNAPOLIS MD 21401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2001-11-05 |