FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2023115
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01667
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE WAS RELOADED. ALSO, THE CUSTOMER WAS INSTRUCTED REGARDING THE PROTECTIVE COVERING OVER THE FOOT PEDAL. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM LOCKED UP AND APPEARED TO PRODUCE FLUOROSCOPY X-RAY WITHOUT COMMAND. NO REPORT OF PT OR STAFF INJURY.
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 |