BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM WAVE MATTRESS

    MDR report key: 7633903 · Received June 25, 2018

    Report

    Report Number
    7633903
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 5, 2018
    Manufacturer
    FREEDOM MEDICAL, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERAPIST ARRIVED AT PATIENT BEDSIDE TO FIND THE BED DEFLATED AND AFTER CHECKING TO SEE THAT THE BED WAS PLUGGED IN, HE UNPLUGGED IT AND REPLUGGED IT IN AND AFTER ABOUT 30 SECONDS THE MACHINE TURNED ON AND THE MATTRESS REINFLATED AFTER ABOUT 2 MINUTES. MANUFACTURER RESPONSE FOR WAVE MATTRESS MALFUNCTION, FREEDOM MEDICAL WAVE MATTRESS (PER SITE REPORTER): EVENTS ARE BEING INVESTIGATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478601 FREEDOM WAVE MATTRESS MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM FREEDOM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1