FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1232589
·
Received November 13, 2008
Report
- Report Number
- 1720753-2008-27984
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 22, 2008
- Report Date
- November 12, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP ARRIVED ON SITE AND WAS UNABLE TO DUPLICATE THE PROBLEM. HE CHECKED CONNECTORS, BOARD SEATING, AND POWER SUPPLIES. ALL WERE OPERATIONAL. HE RE-LOADED THE SOFTWARE. THE SYSTEM OPERATING NORMALLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT NOT ALL SAVED IMAGES COULD BE RECALLED, ALSO, ALL LIGHTS ON C-ARM / WORKSTATION CAME ON (LOCK-UP). A RE-BOOT CLEARED THE PROBLEM BUT SOME SAVED IMAGES WERE STILL MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |