FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 939680
·
Received November 8, 2007
Report
- Report Number
- 1720753-2007-07510
- Event Type
- Malfunction
- Date Received
- November 8, 2007
- Date of Event
- October 17, 2007
- Report Date
- November 8, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DESCRIBED PROBLEMS COULD NOT BE DUPLICATED. ADVISED THE CUSTOMER THAT A FACILITY POWER SAG MAY HAVE CAUSED THE REPORTED ISSUES. CUSTOMER IS MOVING OT A NEW FACILITY AND NO FURTHER ACTION WAS REQUESTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMAGES ON THE 9800 SYSTEM WERE REAL DARK AND THE WORKSTATION WAS PRODUCING A HIGH PITCHED NOISE. THE NOISE WENT AWAY AFTER THE SYSTEM WAS SHUT DOWN AND REPLUGGED IN. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |