FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3811056
·
Received March 24, 2014
Report
- Report Number
- 1720753-2014-02646
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Date of Event
- March 10, 2014
- Report Date
- March 24, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM FROZE AND LOCKED UP WHILE ACQUIRING CINE RUNS. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173378 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |