FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3834475
·
Received March 17, 2014
Report
- Report Number
- 1720753-2014-02400
- Event Type
- Malfunction
- Date Received
- March 17, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 17, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED CHARGING ERRORS AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156906 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |