FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2202588
·
Received August 5, 2011
Report
- Report Number
- 1720753-2011-20764
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE CIRCUIT BOARDS AND ASSOCIATED CABLES WERE RESEATED. THE FLASH MEMORY WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR AND WOULD NOT DISPLAY AN IMAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |