FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2181486
·
Received July 7, 2011
Report
- Report Number
- 1720753-2011-08837
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE NUMBER ONE CIRCUIT BREAKER WAS RESET, TARBALL FILES WERE SENT, AND THE ELECTRICAL SYSTEM VOLTAGES AND MILLIAMPERES WERE LOADED AND CHECKED. 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 SYSTEM DISPLAYED A PRECHARGE VOLTAGE ERROR MESSAGE. 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 |