FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2994202
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01765
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 13, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM INTERFACE BOARD WAS REPLACED 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 AN INTERMITTENT COMMUNICATION FAIL ERROR MESSAGE. THIS MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN SITUATION. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63890 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |