BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM MEDICAL WAVE MATTRESS

    MDR report key: 7518573 · Received May 16, 2018

    Report

    Report Number
    7518573
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 2, 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

    WOUND NURSES RECEIVED CALL FROM NURSING THAT THE ALTERNATING PRESSURE FEATURE ON THE MATTRESS WAS NOT WORKING. PUMP WAS FOUND UNLOCKED, UPRIGHT MODE WAS ENGAGED, FITTED SHEET WAS ON THE BED. THE PUMP WAS RESET THREE TIMES AND THE PROPER INFLATION SETTING DID NOT SEEM TO BE ENGAGED. REQUESTED STAFF PUT THE PROPER LINEN ON THE BED AND CALLED THE COMPANY TO COME AND CHECK THE MATTRESS ISSUE. MANUFACTURER RESPONSE FOR FREEDOM STANDARD WAVE MATTRESS, FREEDOM WAVE MATTRESS (PER SITE REPORTER). THEY ARE WORKING ON RESOLVING THE PROBLEM. NO OTHER RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360606 FREEDOM MEDICAL WAVE MATTRESS MATTRESS, AIR FLOTATION FNM FREEDOM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN/NA