HILL ROM TEMPUR PEDIC COMFORT PAD
Received Jul 25, 2017 · Event occurred Jul 7, 2017
Report 6739743 · MDR key 6739743
Device
Product problems
- Naturally Worn
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ELASTIC BAND NO LONGER FUNCTIONAL. CAUSES OVERLAY TO MOVE ON MATTRESS, EVEN HANG OVER THE EDGES OF THE NORMAL MATTRESS. TRAINING UPON RECEIPT OF THE AFFINITY 4 BEDS: STAFF INSTRUCTED TO PULL OVERLAY OVER THE BED FRAME. ELASTIC QUICKLY WORN OUT IN LESS THAN 1 YEAR, OVERLAYS REPLACED BY HILL-ROM WITH NEW INSTRUCTION TO PULL THE OVERLAY OVER THE MATTRESS, NOT THE BEDFRAME OCCURRED. GATHERING OF TEMPURPEDIC MATERIAL, CAUSING A LATERAL LUMP ACROSS THE LUMBAR AREA. MANY PATIENT COMPLAINTS ABOUT DISCOMFORT WITH THE OVERLAYS. VISIBLE DISCOLORATION OUTLINES WITH IRREGULAR BOARDERS ON THE OVERLAY COVER, DESPITE FOLLOWING MANUFACTURING CLEANING GUIDELINES. MANUFACTURER RESPONSE FOR HILL ROM MATTRESS OVERLAY, HILL ROM MATTRESS OVERLAY (PER SITE REPORTER). HILL-ROM CAME OUT TO ASSESS. NO EXPLANATION OF PROBLEM AND NO OFFER TO REPAIR/REPLACE.