FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 3190037
·
Received June 18, 2013
Report
- Report Number
- 1720753-2013-07366
- Event Type
- Malfunction
- Date Received
- June 18, 2013
- Date of Event
- April 23, 2013
- Report Date
- June 19, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM HAD IMAGES WITH TWO PATIENT NAMES, THEREFORE, IMAGES FROM MULTIPLE PATIENTS APPEARED IN A SINGLE PATIENT STUDY. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276535 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |