FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4214058
·
Received October 24, 2014
Report
- Report Number
- 1720753-2014-08897
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY KEY SWITCH WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN INTERMITTENT KEYSWITCH ERROR MESSAGE ALONG WITH X-RAYS DISABLED MESSAGE. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678092 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |