MalfunctionFLJ
NUAIRE
Received Aug 7, 2013
Report MW5031363 · MDR key 3281854
Device
Generic name
Hoods
Product problems
- Leak/Splash
- Material Twisted/Bent
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THERE ARE SEAMS IN THE METAL USED TO COAT THE PLYWOOD CORE OF THE HOOD. WHEN THE HOODS ARE CLEANED, THE CLEANING FLUID LEAKS IN THE SEAMS, WHICH HAS CAUSED THE WOOD TO WARP. THIS IS AN INFECTION HAZARD. THERE ARE (B)(4) INVOLVED.