FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1011831
·
Received March 11, 2008
Report
- Report Number
- 1720753-2008-17881
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. HOWEVER A SUBSEQUENT INSPECTION FOUND THAT P4/J4 ON THE IMAGE PROCESSOR REQUIRED RESEATING. RESEATING COMPLETED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN IMAGE TAKEN AT THE START OF A PROCEDURE WITH THE 9800 SYS APPEARED TO BE MOTTLED. THE PROCEDURE WAS COMPLETED WITH NO ADD'L PROBLEMS. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |