FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 1362733
·
Received March 5, 2009
Report
- Report Number
- 1720753-2009-01891
- Event Type
- Malfunction
- Date Received
- March 5, 2009
- Date of Event
- February 5, 2009
- Report Date
- March 4, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE GE SERVICE REP INSTALLED A HV CABLE ASSEMBLY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE POWER CORDS GOING INTO THE C-ARM HAD A COVER BROKEN WITH WIRES EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |