FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM
MDR report key: 88324
·
Received April 15, 1997
Report
- Report Number
- 1720753-1997-00006
- Event Type
- Malfunction
- Date Received
- April 15, 1997
- Date of Event
- April 4, 1997
- Report Date
- April 15, 1997
- Manufacturer
- OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON APRIL 4, 1997 CO WAS NOTIFIED THAT AN ACCIDENTIAL RADIATION OCCURRENCE WAS REPORTED TO HAVE OCCURRED TO MODEL 9600 SERIES C-ARM S/N 69-1490. DURING A PROCEDURE THE IMAGE WENT WHITE. SYSTEM WAS REMOVED FROM SERVICE AND A BACK UP SYSTEM WAS USED TO FINISH PROCEDURE. HOSPITAL BIO-MEDICAL DEPARTMENT REPORTED HIGH DOSE OUTPUT. CO FIELD SERVICE DIAGNOSED THE HIGH DOSE OUTPUT, REMOVED AND REPLACED PARTS, TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECIFICATION. HOSPITAL REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY TO PATIENT(S) INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM | MOBILE C-ARM SERIES 9600 | JAA | OEC MEDICAL SYSTEMS, INC. | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |