FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1191332
·
Received October 9, 2008
Report
- Report Number
- 1720753-2008-20050
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 25, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. HOWEVER, IDENTIFIED LOOSE CONNECTIONS ON THE POWER PLUG. TIGHTENED CONNECTIONS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMAGE ON THE 9900 SYSTEM WAS "NOISY". CASE WAS COMPLETED WITH ANOTHER SYSTEM. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |