FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2090579
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06529
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 26, 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 REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE UNIVERSAL NODE ASSEMBLY PRINTED CIRCUIT BOARD, THE CONTROLLER ASSEMBLY PRINTED CIRCUIT BOARD, AND THE SINGLE BOARD COMPUTER CARD WERE RESEATED. THE NODES WERE FLASHED AND REBUILT, AND THE CALIBRATION FILES WERE UPLOADED. THE FOOTSWITCH WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A CASE, THE 6800 SYSTEM AND THE PEDAL WOULD NOT WORK. 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 |