FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4173351
·
Received August 8, 2014
Report
- Report Number
- 1720753-2014-06815
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- July 24, 2014
- Report Date
- August 7, 2014
- 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 ON SITE INVESTIGATION. THE X-RAY TUBE, TUBE COVER AND HIGH VOLTAGE CABLE 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 THE SYSTEM MADE A LOUD CLICK NOISE AND THEREAFTER THE IMAGE BLACKENED. FOLLOWING A REBOOT IT REMAINED FUNCTIONAL FOR A SHORT TIME, BUT THEN REPEATED CHARACTERISTICS OR ARCING AND SHUT DOWN. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471874 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |