FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041519
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02765
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PERFORMED A FILAMENT CALIBRATION AND ADJUSTED THE COLLIMATOR IRIS FOR PROPER IMAGE INTENSIFIER INPUT DOSE, AND CLEANED DEBRIS FROM OF THE IMAGE INTENSIFIER. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE OUTPUT DOSAGE IS TOO HIGH AND THE SYSTEM IS NOT WORKING. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |