FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1071067
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22852
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 24, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP COLLIMATOR IRIS ERROR WAS BEING DISPLAYED DURING BOOTUP. THEY WERE ABLE TO BYPASS BY PRESSING ANY KEY WHEN TRYING TO ADJUST COLLIMATOR. ERRORS WERE ALSO BEING DISPLAYED. THE REP REPLACED FFB AND TESTED SYSTEM. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED COLLIMATOR IRIS POT ERROR. PT INVOLVED, BUT NOT INJURED. THEY WERE ABLE TO COMPLETE PROCEDURE WITHOUT PROBLEM OVER PAST 3 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |