FDA Adverse Event
Malfunction
Summary report: N
MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM
MDR report key: 64662
·
Received January 9, 1997
Report
- Report Number
- 1720753-1997-00001
- Event Type
- Malfunction
- Date Received
- January 9, 1997
- Date of Event
- December 10, 1996
- Report Date
- January 8, 1997
- Manufacturer
- OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 12/13/96, CO RECEIVED NOTIFICATION THAT DURING A PROCEDURE THE VERTICAL COLUMN COLLAPSED TO THE LOWER LIMIT ON MODEL 9000 SERIES C-ARM S/N 99-0434 LOCATED AT HOSP. DURING PROCEDURE, THE SYSTEMS "C" WAS POSITIONED UNDER THE SURGICAL TABLE AND IN THE LATERAL POSITION, THE VERTICAL COLUMN COLLAPSED TO THE LOWER LIMIT. HOSP REMOVED SYSTEM AND USED A PORTABLE BACKUP X-RAY SYSTEM TO COMPLETE THE PROCEDURE. HOSP REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY TO PT INVOLVED. CO FSE DIAGNOSED THE MALFUNCTION TO A BEARING ASSEMBLY IN THE VERTICAL COLUMN. FSE REMOVED AND REPLACED THE SYSTEMS VERTICAL COLUMN, TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM | MOBILE C-ARM SERIES 9000 | JAA | OEC MEDICAL SYSTEMS | 90000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |