FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3042647
·
Received April 2, 2013
Report
- Report Number
- 1720753-2013-04498
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 6, 2013
- Report Date
- April 2, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED DURING THE SERVICE CALL. 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 FLUORO IMAGE WAS JUMPING. THE FSE REPORTED THE LIVE IMAGE IS JUMPING ON THE MONITOR AND THE PRIMARY COLLIMATOR RING IS VISIBLE WHEN THIS HAPPENS. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134944 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |