FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3101388
·
Received May 2, 2013
Report
- Report Number
- 1720753-2013-05573
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- April 3, 2013
- Report Date
- May 2, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE CONNECTORS WERE REGREASED AND A FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS POPPING AND RESULTED IN AN OVERVOLTAGE FAULT ERROR MESSAGE. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192863 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |