MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-25 for * 116 manufactured by Corometric.
[15039293]
Pt was being monitored in the labor room. Smoke was noted to be coming from the unit. The pt was detached from the unit immediately and the unit removed from svc. The pt and the baby were unharmed. The unit was a rental and they were notified and the unit returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 135233 |
| MDR Report Key | 135233 |
| Date Received | 1997-11-25 |
| Date of Report | 1997-11-24 |
| Date of Event | 1997-11-21 |
| Date Facility Aware | 1997-11-21 |
| Report Date | 1997-11-24 |
| Date Added to Maude | 1997-12-03 |
| 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 | * |
| Generic Name | FETAL HEART MONITOR |
| Product Code | HEL |
| Date Received | 1997-11-25 |
| Model Number | 116 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 132125 |
| Manufacturer | COROMETRIC |
| Manufacturer Address | 61 BARNES PARK RD. PO BOX 333 WALLINGFORD CT 06492 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-11-25 |