FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3113069
·
Received May 9, 2013
Report
- Report Number
- 1720753-2013-05875
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 11, 2013
- Report Date
- May 9, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE TANK WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM MONITOR WENT DOWN IN MIDDLE OF PT PROCEDURE. THE FIELD ENGINEER CLARIFIED THAT THE SYSTEM LOCKED UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204911 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |