FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2102115
·
Received April 20, 2011
Report
- Report Number
- 1720753-2011-06384
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE TRANSFORMER TANK WAS REPLACED AND THE FILAMENTS WERE CALIBRATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR MESSAGE. 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 |