FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2172217
·
Received June 15, 2011
Report
- Report Number
- 1720753-2011-08233
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BATTERIES WERE REPLACED AND THE CONNECTIONS OF THE FLUORO FUNCTIONS BOARD, THE GENERATOR INTERFACE BOARD AND THE POWER SUPPLY WERE RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
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 |