FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2193190
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20334
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE, THE BATTERY CHARGER PRINTED CIRCUIT BOARD, AND THE POWER SIGNAL INTERFACE PRINTED CIRCUIT BOARD WERE REPLACED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE AND 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 |