FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1860094
·
Received September 21, 2010
Report
- Report Number
- 1720753-2010-03141
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- September 10, 2010
- Report Date
- September 21, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. 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 WHEN ROTATED TO THE LATERAL POSITION WOULD NOT IMAGE DURING A CASE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. 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 |