FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2101829
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07158
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE KILOVOLTS WERE CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS. THE AUTOMATIC IRIS SETTINGS WERE ADJUSTED WHICH BROUGHT THE MILLIAMPERES DOWN TO THE BASELINE MEASUREMENTS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S MILLIAMPERES SEEMED HIGHER THAN USUAL AND REQUESTED THAT THE MFR CHECK THE AUTOMATIC IRIS ADJUSTMENT. 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 |