FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2102160
·
Received April 20, 2011
Report
- Report Number
- 1720753-2011-06389
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE COLLIMATOR WAS ALIGNED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A PHYSICIST'S DISCREPANCY, THAT THE 9900 SYSTEM HAD A HIGH KILO-VOLTAGE AND IT WOULD NOT COME DOWN. 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 |