FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2090621
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06569
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE GENERAL PURPOSE OPERATING SYSTEM (GPOS), AND RELOADED THE SYSTEM SOFTWARE. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |