MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-03-20 for IMEXDOPCT + manufactured by Nicolet Vascular.
[2397189]
Rn and md got fetal heart tones at 164 twice and ultrasound showed fetal demise. Parents very upset.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2392855 |
| MDR Report Key | 2392855 |
| Report Source | 99 |
| Date Received | 2007-03-20 |
| Date of Report | 2007-03-14 |
| Date of Event | 2007-03-07 |
| Date Facility Aware | 2007-03-07 |
| Report Date | 2007-03-17 |
| Date Added to Maude | 2012-01-03 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FETAL MONITOR |
| Product Code | HEL |
| Date Received | 2007-03-20 |
| Model Number | IMEXDOPCT + |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NICOLET VASCULAR |
| Manufacturer Address | 5225 VERONA RD BLDG 2 MADISON WI 53711 US 53711 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-20 |