FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2152533
·
Received June 22, 2011
Report
- Report Number
- 1720753-2011-08414
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 22, 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 REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED AND THE PRINTED CIRCUIT BOARDS WERE RESEATED. THE GENERATOR INTERFACE BOARD, THE POWER CORD, THE GENERATOR DRIVER BOARD, THE HIGH VOLTAGE SUPPLY BOARD, AND THE HIGH VOLTAGE TRANSFORMER TANK WERE REPLACED. THE GENERATOR AND THE FILAMENTS WERE CALIBRATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM A CINE RUN. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |