FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2241135
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-21129
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 7, 2011
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE TINY TUBE ASSEMBLY AND THE MONOBLOCK CONTROLLER WERE CHECKED. THE POWER SUPPLY, CLOSED CIRCUIT DIGITAL CAMERA, THE ASM CAMERA PART, AND THE PRINTED CIRCUIT BOARD, WERE ALL CHECKED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY IMAGES AFTER FLUOROSCOPIC X-RAYS WERE TAKEN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |