FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2260051
·
Received August 26, 2011
Report
- Report Number
- 1720753-2011-21406
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE INTERCONNECT CABLE, THE LEMO CONNECTOR, AND ALL THE CIRCUIT BOARDS WERE CHECKED. THE VOLTAGE WAS CHECKED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |