inforMED
MalfunctionFMW

TEMPUR MED PRESSURE REDUCING PRODUCT

Received Apr 26, 2012 · Event occurred Apr 24, 2012

Report 2557908 · MDR key 2557908

Device

Generic name

Mattress Tabletop-wide

Manufacturer

Tempur Med

Model number

*

Catalog number

*

Lot number

*

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.