MalfunctionFLF
STERRAD 200 STERILIZATION SYSTEM
Received Sep 25, 2007 · Event occurred Aug 30, 2007
Report 2084725-2007-00272 · MDR key 918240
Device
Generic name
Sterilizer
Manufacturer
Yamato Lab-tech Co, LtdModel number
10201-002Catalog number
NA
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED OIL MIST COMING FROM THEIR UNIT. THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE REPORTED OIL MIST. THE ASP FIELD SERVICE ENGINEER REPAIRED THE UNIT.
Remedial action
- Other