FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1232525
·
Received November 13, 2008
Report
- Report Number
- 1720753-2008-28061
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 16, 2008
- Report Date
- November 13, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO GE HEALTHCARE. THE GE SERVICE REP REPLACED THE LEFT MONITOR AND VERIFIED THAT THE FLICKERING WAS GONE. HE DETERMINED THAT THE HV CABLE ASSEMBLY HAD A BROKEN WIRE, SO HE REPLACED THE HV CABLE ASSEMBLY. THE REP VERIFIED ALL CONTROLS ON THE DOGHOUSE ASSEMBLY WERE FUNCTIONING PROPERLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SCREENS ARE FLICKERING AND THE LINE COLLIMATOR IS FROZEN.
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 |