FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2971189
·
Received February 1, 2013
Report
- Report Number
- 1720753-2013-01385
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 23, 2013
- Report Date
- February 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED DURING THE SVC CALL. THE SYS WAS TESTED ADN FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYS DISPLAYED A COMMUNICATION ERROR MESSAGE, AND WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45380 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |