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.
[103411374]
Baby had a deceleration and the nurse could hear it, but then the tracing fell off so could not see it (there was so much background noise that the nurse could not hear the fetal heart tones after the tracing fell off).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076048 |
| MDR Report Key | 7366016 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-03-12 |
| 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 | PENNATAL MONITOR |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |