FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 2092190
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06620
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPAIRED AND ALL CONNECTIONS WERE RESEATED. THE SYSTEM WAS TESTED AND THE IMAGE INTENSIFIER AND THE POWER SUPPLY NEEDED TO BE REPLACED, HOWEVER, THOSE PARTS WERE NO LONGER AVAILABLE. THE SYSTEM REMAINS DOWN AND THE MFR'S REP RECOMMENDED THAT THE SYSTEM BE REMOVED FROM SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6600 SYSTEM MADE A BUZZING SOUND WHEN IT WAS POWERED ON. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |