FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1071125
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22904
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 25, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP REPLACED THE POWER SUPPLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED NO VERTICAL MOVEMENTS WITH NO ERROR DISPLAYED. THE PROBLEM OCCURRED IN PREPARATION FOR PROCEDURE. THEY WERE ABLE TO COMPLETE THE PROCEDURE. NO PT INJURIES WERE RECORDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |