FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1864929
·
Received October 6, 2010
Report
- Report Number
- 1720753-2010-03401
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE LEFT MONITOR 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
IT WAS REPORTED THAT THE 9800 SYSTEM HAD NO IMAGE DISPLAYED ON THE LEFT MONITOR DURING A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |