FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2101626
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07223
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CENTRAL PROCESSING UNIT BATTERY WAS REPLACED AND THE BIOS WAS CONFIGURED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITORS OF THE SYSTEM WOULD NOT TURN ON. 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 |