FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1980043
·
Received January 24, 2011
Report
- Report Number
- 1720753-2011-00507
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION AND VERIFIED THE CORRECT DOSE RATES WITH A RADCAL DOSIMETER. READINGS WERE 8.7 R/MIN IN FLUORO, 17.8 R/MIN IN HIGH LEVEL FLUORO. THE SWITCH BUTTONS ON THE FOOTSWITCH WERE REMOVED AND CORRECTED, AND THE HAND CONTROLLER WAS REPLACED. THE SYSTEM WAS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A PHYSICIST DISCREPANCY WITH THE DOSE RATE ON THE 9800 SYSTEM AND THE FUNCTIONS ON THE FOOTSWITCH ARE REVERSED. THE CUSTOMER ALSO REPORTED A SHORT IN THE HAND CONTROL AND THE VERTICAL COLUMN OPERATES INCONSISTENTLY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |