FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3791932
·
Received January 3, 2014
Report
- Report Number
- 1720753-2014-00070
- Event Type
- Malfunction
- Date Received
- January 3, 2014
- Date of Event
- December 16, 2013
- Report Date
- January 3, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MAINFRAME BATTERY PACKS AND BATTER CHARGING PCB WERE EVALUATED AND REPLACED. 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 EXHIBITED 'PRE-CHARGE ERRORS' UPON SYSTEM START UP. THIS ERROR IS LIKELY TO PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4153 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |