FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4063236
·
Received August 8, 2014
Report
- Report Number
- 1720753-2014-06868
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- July 1, 2014
- Report Date
- August 8, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE VOLTAGE ON GIB WAS EVALUATED AND READJUSTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE FE REPORTED A COMMUNICATION ERROR AND A LOSS OF X-RAY CAPABILITIES. THIS RESULTED A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472878 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |