FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM
MDR report key: 200344
·
Received December 2, 1998
Report
- Report Number
- 1720753-1998-00015
- Event Type
- Malfunction
- Date Received
- December 2, 1998
- Date of Event
- November 3, 1998
- Report Date
- December 1, 1998
- Manufacturer
- OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 11/6/98 OEC MEDICAL SYSTEMS, INC WAS NOTIFIED OF AN INCIDENT INVOLVING AN OEC MODEL 9600 SERIES C-ARM. AFTER A CATHETERIZATION PROCEDURE THE DR ATTEMPTED TO RECALL AND REVIEW STORED IMAGES, BUT COULD NOT FIND THEM. THE PROCEDURE WAS REPEATED RESULTING IN ADD'L RADIATION AND CONTRAST MEDIA TO THE PT. NO FURTHER MEDICAL INTERVENTION OR INJURY WAS REPORTED. OEC ENGINEERING HAS DETERMINED THAT UNDER VERY SPECIFIC AND UNUSUAL CONDITIONS, I.E. FIELD SERVICE INTERVENTION, THE FIRST STORED CINE RUNS CAN NOT BE CALLED UP ON THE REVIEW STATION.
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 | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |