FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2100235
·
Received May 16, 2011
Report
- Report Number
- 1720753-2011-07350
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SVC REP REPLACED THE GENERATOR INTERFACE BOARD AND ADJUSTED THE VOLTAGE AT THE FLUORO FUNCTIONS PRINTED CIRCUIT BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD CONTINUE TO X-RAY AFTER RELEASE OF THE SWITCH. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |