FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1992875
·
Received February 5, 2011
Report
- Report Number
- 1720753-2011-00957
- Event Type
- Malfunction
- Date Received
- February 5, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 5, 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
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND TIGHTENED THE COLLIMATOR IRIS CLUTCH, REPLACED THE WORKSTATION AND TECH PROCESSOR BATTERIES, AND RESEATED WORKSTATION CIRCUIT BOARDS. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WILL NOT BOOT UP OR WILL DISPLAY A COLLIMATOR ERROR. 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 |