FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2243644
·
Received August 24, 2011
Report
- Report Number
- 1720753-2011-21349
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SKIN DOSE RATE AND AUTO TECHNIQUE TRACKING WERE CHECKED. THE GIB COIN BATTERY WAS REPLACED. THE LO MA NULL AND HI MA NULL WERE ADJUSTED AND GENERATOR AND FILAMENT/DUTY CYCLE CALIBRATIONS WERE PERFORMED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN ERROR MESSAGE READING RADIATION LEVELS HIGH WAS DISPLAYED ON THE SYS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |