FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2150936
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08351
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ON SITE INVESTIGATION. THE SRAM BATTERY WAS REPLACED. THE CUSTOMER DECLINED TO HAVE THE REP REPAIR THE X-RAY TUBE. THE CUSTOMER PLANS TO REPLACE THE SYS. NO FURTHER SVC INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS DISPLAYING POOR IMAGE QUALITY. THIS EVENT OCCURRED DURING A PROCEDURE. 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 |