FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2093067
·
Received May 3, 2011
Report
- Report Number
- 1720753-2011-06856
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 7, 2011
- Report Date
- May 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE HIGH VOLTAGE CABLE AND COLLIMATOR WERE REPLACED. THE HARDWARE IN THE POWER CAP MODULE WAS SECURED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE COLLIMATOR DOES NOT ROTATE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |