FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2935357
·
Received January 14, 2013
Report
- Report Number
- 1720753-2013-00570
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 14, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM EXHIBITED FAILED SAVED DATA ERRORS. THIS ERROR WILL PRECLUDE THE SYSTEM FROM PROPERLY SAVING PATIENT IMAGE DATA. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21285 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |