FDA Adverse Event
Death
Summary report: N
COROMETRICS 259
MDR report key: 854338
·
Received May 23, 2007
Report
- Report Number
- 2124823-2007-00049
- Event Type
- Death
- Date Received
- May 23, 2007
- Date of Event
- March 8, 2007
- Report Date
- May 23, 2007
- Manufacturer
- GE HEALTHCARE
- Product Code
- KXN
- PMA / PMN Number
- K050583
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ACCORDING TO USER FILED MEDWATCH REPORT, BIOMED WAS CHECKING THE FETAL ECG CABLE THAT WAS USED ON A LABORING PT AND NOTED IT WAS NOT OPERATIONAL. INFANT WAS REPORTEDLY BORN WITH BRADYCARDIA AND ANOXIA AND SUBSEQUENTLY DIED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROMETRICS 259 | MATERNAL/FETAL MONITOR | KXN | GE HEALTHCARE | COROMETRICS 259 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Death |