FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3862894
·
Received February 20, 2014
Report
- Report Number
- 1720753-2014-01690
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- February 17, 2014
- Report Date
- February 20, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE UPS BATTERY WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO WORKING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP DURING USE. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106746 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |