FDA Adverse Event
Death
Summary report: N
COROMETRICS 120 SERIES MATERNAL FETAL MONITOR
MDR report key: 1178643
·
Received September 26, 2008
Report
- Report Number
- 9617277-2008-00001
- Event Type
- Death
- Date Received
- September 26, 2008
- Date of Event
- April 23, 2008
- Manufacturer
- OHMEDA MEDICAL
- Product Code
- HGM
- PMA / PMN Number
- K032252
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE HAS EVALUATED THE UNIT AND IT WAS FOUND TO PERFORM IN ACCORDANCE WITH ITS SPECS. NO MALFUNCTION WAS DETECTED. THE TRACING RECEIVED FROM THE HOSP INDICATED THAT THE CHILD WAS BORN ALIVE AND SUBSEQUENTLY PASSED AWAY AFTER 5 HOURS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ULTRASOUND MEASUREMENTS WERE RECEIVED FROM THE CORO 120 MONITOR EVEN THOUGH THE FETUS HAD DIED 30 MINUTES PRIOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROMETRICS 120 SERIES MATERNAL FETAL MONITOR | MATERNAL FETAL MONITOR | HGM | OHMEDA MEDICAL | CORO 120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 HR | Death |