FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2152592
·
Received June 27, 2011
Report
- Report Number
- 1720753-2011-08542
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE TECHNICAL PROCESSOR PRINTED CIRCUIT BOARD, AND THE SRAM CARD, AND RECONFIGURED THE OBTUSER FILE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT MOVE UP OR DOWN. NO PATIENT 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 |