FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041346
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02700
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND ADJUSTED THE MAG2 FOR CORRECT SIZING AND THE IMAGE INTENSIFIER GRID VOLTAGE TO MAKE THE ACTUAL VS VIEWED IMAGE SIZES LESS THAN 4%. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED MAG2 ACTUAL IMAGE SIZE EXCEEDS VIEWED IMAGE SIZE BY GREATER THAN 4%. NO PT 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 |