FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1021761
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19789
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. HOWEVER REPLACED THE GENERATOR BATTERIES. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PLACED BACK INTO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYS DISPLAYED A "CHARGER FAIL" ERROR CODE. THE CASE, HOWEVER, WAS COMPLETED AND THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |