FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1890281
·
Received October 22, 2010
Report
- Report Number
- 1720753-2010-03714
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 29, 2010
- Report Date
- October 22, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE COLLIMATOR, SRAM MEMORY, RELOADED SOFTWARE, AND CALIBRATED THE COLLIMATOR. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM DISPLAYED A COLLIMATOR IRIS POTENTIOMETER ERROR ON BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |