FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2102699
·
Received May 23, 2011
Report
- Report Number
- 1720753-2011-07514
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- May 11, 2011
- Report Date
- May 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED ON ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE CAMERA AND THE VIDEO CONTROLLER PRINTED CIRCUIT BOARD AND THE BACKPLANE AS WELL AS RESEATED THE CONNECTOR AT THE INCOMING POWER. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A LIVE IMAGE AND THE HAND CONTROL WOULD NOT WORK PROPERLY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |