FDA Adverse Event
Malfunction
Summary report: N
AVALON FM30
MDR report key: 858147
·
Received October 6, 2006
Report
- Report Number
- 9610816-2006-00310
- Event Type
- Malfunction
- Date Received
- October 6, 2006
- Date of Event
- September 3, 2006
- Report Date
- September 5, 2006
- Manufacturer
- PHILIPS MEDIZINSYSTEME BOBLINGEN
- Product Code
- HGM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE USER WAS HAVING DIFFICULTY WITH GETTING THE FETAL HEART RATE (FHR) ON THE MONITOR AND THE FHR TRACE WOULD NOT PRINT OUT. THE USER STATED THAT THEY COULD NOT HEAR THE FHR, THERE WAS NO DISPLAY, AND NO PRINTOUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVALON FM30 | FETAL MONITOR | HGM | PHILIPS MEDIZINSYSTEME BOBLINGEN | M2703A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |