FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4223509
·
Received August 6, 2014
Report
- Report Number
- 1720753-2014-06768
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 23, 2014
- Report Date
- August 6, 2014
- 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 HIGH VOLTAGE TANK, IGBT ASSEMBLY, HIGH VOLTAGE REGULATOR PCB AND GENERATOR DRIVER PCB, AND X-RAY TUBE WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS AN 'SATURATION FAULT' ERROR MESSAGE DISPLAYED. THIS ERROR IS LIKELY TO RESULT IN AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460687 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |