FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3231038
·
Received July 12, 2013
Report
- Report Number
- 1720753-2013-08083
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 27, 2013
- Report Date
- July 12, 2013
- 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 SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. AN SBC UPGRADE WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE SYSTEM WAS DISPLAYING ERRORS AND LOCKING UP. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323236 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |