BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY

    MDR report key: 7453674 · Received April 24, 2018

    Report

    Report Number
    7453674
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 21, 2018
    Report Date
    April 13, 2018
    Manufacturer
    FREEDOM MEDICAL, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON A BARIATRIC FREEDOM WAVE MATTRESS THAT STAYED OVER INFLATED. IT WAS THOUGHT TO BE A PROBLEM WITH THE PUMP. WE HAVE HAD SEVERAL AT LEAST 7 OTHER EVENTS ABOUT PATIENTS WITH PRESSURE ULCERS. THESE EVENTS ALL INVOLVED A MALFUNCTIONING FREEDOM WAVE MATTRESS, BUT AT THE TIME NO ONE RELATED THE ISSUE TO POSSIBLY BEING THE MALFUNCTIONING FREEDOM WAVE MATTRESS. MANUFACTURER RESPONSE FOR FREEDOM MEDICAL WAVE MATTRESS WITH SMART WAVE TECHNOLOGY, FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY (PER SITE REPORTER). THE MANUFACTURER REPRESENTATIVE CAME IN TO LOOK AT THE MALFUNCTIONING BED/MATTRESS SYSTEM AND REPLACED ALL THE MOTORS BUT THIS DID NOT SEEM TO RESOLVE THE PROBLEM. AT THIS TIME, THE DECISION HAS BEEN MADE TO NO LONGER USE THIS MATTRESS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296644 FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM FREEDOM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1