FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152430
·
Received June 28, 2011
Report
- Report Number
- 1720753-2011-08578
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE REAL TIME OPERATING SYSTEM PRINTED CIRCUIT BOARD, RELOADED THE SOFTWARE, AND INSPECTED THE ESD KIT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT 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 |