BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 8222271 · Received January 7, 2019

    Report

    Report Number
    3009402404-2019-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 26, 2018
    Report Date
    January 7, 2019
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "THE PATIENT SLID OUT OF BED IN THE MORNING WHILE HAVING A MUSCLE SPASM WHILE SHE WAS AWAKE. PATIENT IS UNABLE TO SPEAK BUT HAD NO INJURIES AFTER SHE WAS EXAMINED." (B)(4) AND (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE MATTRESS AND CONTROL UNIT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE MATTRESS AND CONTROL UNIT HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14127 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM FXI DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 MO