FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3832635
·
Received March 27, 2014
Report
- Report Number
- 1720753-2014-02723
- Event Type
- Malfunction
- Date Received
- March 27, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 27, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BATTERY CHARGER BOARD WAS EVALUATED, REPLACED AND RECALIBRATED. 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 VOLTAGE ERRORS' UPON SYSTEM START UP. THIS ERROR IS LIKELY TO PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179340 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |