MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-04-16 for COROMETRIC FETAL ECG CABLE UNK 1591AAO manufactured by Ge Medical Systems.
[18968499]
In 2007, biomed was checking a fetal ecg cable used on a laboring pt. The cable was found to not be operational. Fetal bradycardia noted. Baby apgars 1-3-3. Baby expired at another facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 839173 |
| MDR Report Key | 839173 |
| Report Source | 99 |
| Date Received | 2007-04-16 |
| Date of Report | 2007-04-15 |
| Date of Event | 2007-04-12 |
| Report Date | 2007-04-15 |
| Date Reported to FDA | 2007-04-16 |
| Date Reported to Mfgr | 2007-04-16 |
| Date Added to Maude | 2007-04-20 |
| 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 | RISK MANAGER |
| 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 |
| Brand Name | COROMETRIC FETAL ECG CABLE |
| Generic Name | FETAL ECG CABLE |
| Product Code | KXN |
| Date Received | 2007-04-16 |
| Model Number | UNK |
| Catalog Number | 1591AAO |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 DAY |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 826573 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | * JUPITER FL 33468 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-04-16 |