FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 2565861
·
Received May 3, 2012
Report
- Report Number
- 1720753-2012-03302
- Event Type
- Malfunction
- Date Received
- May 3, 2012
- Date of Event
- February 8, 2012
- Report Date
- May 3, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND FOUND THE SYSTEM SOFTWARE NEEDED TO BE RELOADED. THE CUSTOMER DID NOT HAVE A BACK UP COPY OF THE SOFTWARE, AND IT IS NO LONGER AVAILABLE THROUGH GE. GE IS NOT ABLE TO REPAIR THIS SYSTEM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |