FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1864969
·
Received October 6, 2010
Report
- Report Number
- 1720753-2010-03407
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 16, 2010
- Report Date
- October 6, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE AND PERFORMED A CAMERA ALIGNMENT. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THERE WAS NO IMAGE ON THE LEFT MONITOR AND THE SYSTEM WOULD NOT PRODUCE X-RAYS DURING A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |