FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2152657
·
Received June 24, 2011
Report
- Report Number
- 1720753-2011-08488
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE CIRCUIT BOARDS WERE RESEATED. THE COLLIMATOR WAS CALIBRATED. THE IMAGE INTENSIFIER HANDLE WAS TIGHTENED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A BAD IRIS POTENTIOMETER ERROR MESSAGE. 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 |