FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3960715
·
Received June 9, 2014
Report
- Report Number
- 1720753-2014-04814
- Event Type
- Malfunction
- Date Received
- June 9, 2014
- Date of Event
- May 20, 2014
- Report Date
- June 9, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A STOP ACTIVATED ERROR MESSAGE. THIS CAUSES THE SYSTEM TO SHUT DOWN, RESULTING IN A 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 |
|---|---|---|---|---|---|---|---|
| 333963 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |