MalfunctionFLF
STERRAD 200 STERILIZATION SYSTEM
Received Sep 25, 2007 · Event occurred Aug 28, 2007
Report 2084725-2007-00270 · MDR key 918242
Device
Generic name
Sterilizer
Manufacturer
Yamato Lab-tech Co., LtdModel number
10201-001Catalog number
NA
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A HAZE COMING FROM THEIR UNIT. THE CUSTOMER STATED THAT THERE WERE NO REPORTS OF PHYSICIAL SYMPTOMS RELATED TO THE OIL MIST. THE ASP FIELD SVC ENGINEER WENT TO THE FACILITY TO REPAIR THE UNIT.
Remedial action
- Other