FDA Adverse Event
Summary report: N
SKYTRON
MDR report key: 2021724
·
Received March 3, 2011
Report
- Report Number
- 1825014-2011-00003
- Date Received
- March 3, 2011
- Report Date
- March 2, 2011
- Manufacturer
- MIZUKO
- Product Code
- GDC
- Report Source
- Distributor report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IN RESPONSE TO UCLA'S MDR # 0502620000-2011-8006. SKYTRON'S DISTRIBUTOR IN THE LOS ANGLES AREA, INTEGRATED MEDICAL, SPOKE TO THE FACILITY'S BIO-TECHNICIAN WHO INFORMED HIM THAT THE TABLE HAD BEEN ALREADY BEEN REPAIRED ON JANUARY 13, 2011. DUE TO THE AGE OF THE TABLE, APPROX 22 YEARS, THE CONSTANT FLUID EGRESS OVER THAT LENGTH OF TIME CAUSED CORROSION TO THE FOOT/LEG PIN CAUSING THE FOOT/LEG SECTION TO STICK. THE TECHNICIAN CLEANED THE AREA AND APPLIED LUBRICANT TO THE PIN. THE TABLE WAS CLEARED FOR USE. AGE OF TABLE BEYOND ITS 'LIFE' EXPECTANCY OF APPROX 10 YEARS UNDER NORMAL USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SKYTRON | SURGICAL TABLE | GDC | MIZUKO | 3100 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |