FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3792173
·
Received January 8, 2014
Report
- Report Number
- 1720753-2014-00239
- Event Type
- Malfunction
- Date Received
- January 8, 2014
- Date of Event
- December 12, 2013
- Report Date
- January 8, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED. THE BOARDS AND CONNECTORS WERE RESEATED 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 DISPLAYED COMMUNICATION ERROR. A COMMUNICATION FAILURE ERROR MESSAGE IS LIKELY RESULT IN A SYS LOCK UP, NO BOOT, OR SHUT DOWN SITUATION.. THERE ARE NO REPORT OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12675 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |