FDA Adverse Event
Death
Summary report: N
AVALON FM50 FETAL MONITOR
MDR report key: 1675636
·
Received April 27, 2010
Report
- Report Number
- 9610816-2010-00119
- Event Type
- Death
- Date Received
- April 27, 2010
- Report Date
- March 22, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HGM
- PMA / PMN Number
- K071800
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED A FETAL DEATH. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR ANY FAILURE TO PERFORM AS INTENDED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FETAL DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVALON FM50 FETAL MONITOR | HGM | PHILIPS MEDICAL SYSTEMS | M2705A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |