FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2072460
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03500
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 8, 2011
- 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
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE CONNECTORS IN THE CONTROL PANEL WERE RESEATED, THE NODES WERE FLASHED AND THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 2800 SYSTEM'S CONTROL PANEL LOCKED UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |