FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4180686
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08641
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 8, 2014
- Report Date
- October 15, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER CORD AND THE SOFTWARE WERE INSTALLED 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 THE SYSTEM WAS NOT BOOTING PROPERLY AND AN ERROR MESSAGE WAS DISPLAYED. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653878 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |