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 |