FDA Adverse Event
Malfunction
Summary report: N
GE OEC 2600
MDR report key: 1040752
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21407
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 29, 2008
- Report Date
- May 8, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP CORRECTED BEAM CENTERING TO BE WITHIN 2% OF S.I.D.. MEASURED RADIOGRAPHIC KVP AND ENSURED THAT THE KVP'S ARE WITHIN 5% TOLERANCE. ADJUSTED MA LIMIT FILE TO LIMIT MAX R IN NORMAL MODE. AND, CLEANED AND CALIBRATED FILMER TO ALLOW CASSETTE TO MOVE SMOOTHLY. UNIT NOW OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE FLUOROSCOPIC BEAM CENTERING ERROR EXCEEDS 2% OF THE SID TOLERANCE, RADIOGRAPHIC KV ERROR EXCEEDS 5% TOLERANCE. THE MAXIMUM FLUORO ENTRANCE EXPOSURE RATE EXCEEDS 10R/MIN IN THE NORMAL MODE. ALSO, INTERMITTENTLY THE CASSETTE DOES NOT TRAVEL TO THE FILM POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |