FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3161725
·
Received June 3, 2013
Report
- Report Number
- 1720753-2013-06715
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 22, 2013
- Report Date
- June 4, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SNUBBER BOARD, X-RAY TUBE, HIGH VOLTAGE TANK AND TUNING COIL WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR MESSAGE, SHUT ITSELF DOWN, AND THEN WOULD NOT REBOOT. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243557 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |