TEMPUR MED PRESSURE REDUCING PRODUCT
Received Apr 26, 2012 · Event occurred Apr 24, 2012
Report 2557908 · MDR key 2557908
Device
Product problems
- Contamination
- Material Discolored
Patient
*
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WE HAVE DISCOVERED IN TWO (2) DIFFERENT DEPARTMENTS IN THE FACILITY BLOOD & MOLD STAINS ON THE CUSHIONS THAT ARE WITHIN AN IMPERMEABLE COVER. THE CUSHION AND COVER ARE MANUFACTURED BY ONE COMPANY BUT SOLD BY ANOTHER COMPANY AS PART OF THEIR PROCEDURE TABLE FOR THE INTERVENTIONAL RADIOLOGY DEPARTMENT AND ENDOVASCULAR LAB.======================MANUFACTURER RESPONSE FOR MATTRESS TABLETOP-WIDE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================MANUFACTUER'S REP WAS PRESENT ONCE WE DISCOVERED THE MOLD AND BLOOD STAINS ON CUSHION. PERFORATIONS IN THE CUSHION COVER COULD NOT BE DETECTED, LEAKS APPEARED TO HAVE COME FROM SEAMS. MANUFACTURER'S REP MAKING ARRANGEMENTS TO TAKE PRODUCT FOR INSPECTION.