FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2093342
·
Received May 4, 2011
Report
- Report Number
- 1720753-2011-06898
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE FOOT SWITCH, THE SINGLE BOARD COMPUTER, AND THE HARD DRIVE WERE REPLACED. THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE FOOT SWITCH WOULD NOT WORK ON THE SYSTEM. NO PT 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 |