FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2030993
·
Received March 4, 2011
Report
- Report Number
- 1720753-2011-01930
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 8, 2011
- Report Date
- March 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE C-CRADLE BRAKE PAD WAS CLEANED, THE WORKSTATION POWER SUPPLY WAS ADJUSTED, AND THE HIGH VOLTAGE CABLE ASSEMBLY WIRES WERE REPAIRED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT MONITOR WENT BLACK ON THE 9600 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |