FDA Adverse Event
Death
Summary report: N
AVALON FM30 FETAL MONITOR
MDR report key: 3952283
·
Received July 16, 2014
Report
- Report Number
- 9610816-2014-00190
- Event Type
- Death
- Date Received
- July 16, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 4, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HGM
- PMA / PMN Number
- K052795
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATED AFTER A C-SECTION THE A BABY WAS BORN DEAD/STILLBORN AND THE CUSTOMER STATES THAT THE M2703A AVALON FM30 FETAL MONITOR S/N: (B)(4) DID PICK UP A FETAL HEART RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 415863 | AVALON FM30 FETAL MONITOR | SYSTEM, MONITORING, PERINATAL | HGM | PHILIPS MEDICAL SYSTEMS | M2703A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |