FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2102715
·
Received May 23, 2011
Report
- Report Number
- 1720753-2011-07512
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP RETRIEVED THE LOG FILES, ADJUSTED THE 5VDC AT THE WORKSTATION AND THE BACKPLANE, FLASHED THE NODES, REPLACED THE TABLE GENERATOR INTERFACE PRINTED CIRCUIT BOARD AND THE HAND CONTROL, RELOADED THE CONFIGURATION AND THE CALIBRATION FILES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEMS' HAND CONTROL WOULD NOT WORK. NO PT 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 |