FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2100388
·
Received May 13, 2011
Report
- Report Number
- 1720753-2011-07317
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE X-RAY TUBE, THE HIGH VOLTAGE SUPPLY REGULATOR BOARD, AND THE GENERATOR DRIVER BOARD WERE REPLACED. THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS CALIBRATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS EVENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN X-RAY DISABLED ERROR MESSAGE. NO PATIENT 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 |