FDA Adverse Event
Other
Summary report: N
STAN S31 FETAL HEART MONITOR
MDR report key: 1819959
·
Received August 25, 2010
Report
- Report Number
- 3004729605-2010-00010
- Event Type
- Other
- Date Received
- August 25, 2010
- Date of Event
- November 21, 2009
- Report Date
- August 20, 2010
- Manufacturer
- NEOVENTA MEDICAL AB
- Product Code
- HEO
- PMA / PMN Number
- P020001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE CONCLUDE THAT THE EVENT IS RETROSPECTIVELY REPORTABLE TO THE FDA IN ACCORDANCE WITH (B)(4).
Description of Event or Problem · 1
THERE WAS NO DEATH OR SERIOUS INJURY, BUT THE BABY WAS BORN WITH LOW APGAR SCORES (B)(6) 2009, AND METABOLIC ACIDOSIS ACCORDING TO CORD GASES (ART PH 6.75 VEIN PH 6.82), NEEDED RESUSCITATION AND WAS TRANSFERRED TO (B)(6). DESPITE A DETERIORATING FETAL HEART RATE TRACING AND ST EVENTS, THE PROVIDER CONTINUED LABOR FOR 60 MINUTES BEFORE PERFORMING A C/S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAN S31 FETAL HEART MONITOR | HEO: OBSTETRIC DATA ANALYZER | HEO | NEOVENTA MEDICAL AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Required Intervention |