FDA Adverse Event
Death
Summary report: N
PHILIPS AVALON FM50
MDR report key: 1579412
·
Received January 8, 2010
Report
- Report Number
- 1579412
- Event Type
- Death
- Date Received
- January 8, 2010
- Date of Event
- November 30, 2009
- Report Date
- January 8, 2010
- Manufacturer
- PHILIPS HEALTHCARE, INC.
- Product Code
- HGM
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A PT PRESENTING TO LABOR AND DELIVERY IN LABOR. AT 41 WEEK GESTATION AND HISTORY OF PRIOR PLANNED C-SECTION FOR TWINS. PATIENT PLACED ON FM20 PHILIPS AVALON. MONITOR WAS ERRATIC WITH TRACINGS AND AT ONE POINT, IT WAS DIFFICULT TO DISTINGUISH MOM AND BABY'S HEART RATE ON THE TRACING, BUT THE DIGITAL READOUT WAS 30 BEATS APART. ULTRASOUND SHOWED NO HEART BEAT. EMERGENCY C-SECTION WAS PERFORMED AND THE INFANT HAD AN APGAR OF 0,0. THE INFANT WAS RESUSCITATED AND TRANSFERRED TO FACILITY WITH HIGHER LEVEL OF CARE IN NICU. THE BABY DID NOT SURVIVE, DYING THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS AVALON FM50 | FETAL MONITOR | HGM | PHILIPS HEALTHCARE, INC. | FM 20 | 865701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Death | HAND-HELD DOPPLER| INTERNAL FETAL MONITOR |