MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-28 for FETAL MONITOR 115 manufactured by Corometric Medical Systems, Inc..
[18953103]
Monitor possibly contributed to prolonged hospitalization. Mother with high risk due to preeclampsia, was on pitocin and mgso4 iv's ongoing. External fetal monitor indicated decelerations. Iupc placed on and iupc cable switches not connecting well, adjusted, epidural placement done; machine appeared to be skipping when marking fhr. External monitor reapplied and different fhr obtained; nursing interventions performed due to fhr. A second internal monitoring unit was obtained and non-reassuring fhr was confirmed; c-section performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003855 |
| MDR Report Key | 17273 |
| Date Received | 1994-10-28 |
| Date of Report | 1994-10-20 |
| Date of Event | 1994-10-11 |
| Date Added to Maude | 1994-10-31 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL MONITOR |
| Generic Name | FETAL MONITOR |
| Product Code | KXN |
| Date Received | 1994-10-28 |
| Model Number | 115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17205 |
| Manufacturer | COROMETRIC MEDICAL SYSTEMS, INC. |
| Manufacturer Address | WALLINGFORD CT 06492 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-28 |