FDA Adverse Event
Injury
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 905752
·
Received August 30, 2007
Report
- Report Number
- 1720753-2007-04912
- Event Type
- Injury
- Date Received
- August 30, 2007
- Date of Event
- June 27, 2007
- Report Date
- August 30, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. THE INVESTIGATION INDICATED THAT THERE WAS DEBRIS IN THE WHEEL ASSEMBLY. THE DEBRIS WAS REMOVED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE. NO ADD'L OPERATOR INFO PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT WHEEL OF THE 9800 SYSTEM WILL CATCH AND BIND AS THE OPERATOR IS MOVING THE SYSTEM. WHILE PULLING THE MACHINE BACK THE MACHINE "ROLLED" ON THE OPERATOR'S ANKLE. THE OPERATOR RECEIVED A BRUISED ANKLE. NO ADD'L INFO AVAILABLE REGARDING THE OPERATOR'S CONDITION OR IF FOLLOW-UP TREATMENT WAS REQUIRED.
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 | YR | Other |