MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for GE COROMETRIC ELECTRONIC FETAL MONITOR manufactured by Ge.
[103405450]
Being monitored prior to c section, baby had a deceleration and the tracing dropped off. Lot of background noise so it was difficult to hear the heart rate as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076046 |
| MDR Report Key | 7365931 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-03-13 |
| Date Added to Maude | 2018-03-23 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE COROMETRIC ELECTRONIC FETAL MONITOR |
| Generic Name | MONITOR, HEART RATE, FETAL, ULTRASONIC |
| Product Code | HEL |
| Date Received | 2018-03-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |