FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3042576
·
Received April 2, 2013
Report
- Report Number
- 1720753-2013-04520
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 2, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FLUORO SWITCH WAS CLEANED. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATING AS INTENDED. THE MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT, AFTER RELEASING THE FLUORO BUTTON, THE FLUORO CONTINUED BRIEFLY. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134891 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |