FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1812122
·
Received August 17, 2010
Report
- Report Number
- 1720753-2010-02566
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 17, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REMOVED AND REPLACED THE TABLE FOOTSWITCH. TESTED SYSTEM BY BOOTING SYSTEM WITH NO ERRORS. MOVED TABLE IN ALL DIRECTIONS WITH FOOTSWITCH WITH NO PROBLEMS. SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE TABLE FOOT CONTROL IS INTERMITTENT AND THE CORD'S OUTER SHIELDING IS TORN. 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 |