FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1993254
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-01053
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 21, 2011
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE GE REP CHECKED THE SYSTEM LOGS AND FOUND WHERE SUBTRACTION IMAGES WERE PRODUCED, SAVED, AND PLAYED BACK. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEM WOULD NOT RECALL SUBTRACTION IMAGES. 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 |