FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 2101596
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07172
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE SOFTWARE WAS RELOADED AND A NEW TABLE CALIBRATION DISK WAS MADE. THE AC POWER PLUG WAS PLACED ON THE CORRECT PINS. THE COLLIMATOR BLADES WERE ALIGNED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TABLE ON THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |