BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 7327731 · Received March 9, 2018

    Report

    Report Number
    3009402404-2018-00012
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 25, 2018
    Report Date
    March 9, 2018
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, FACILITY IS STATING THAT THE PATIENT REACHED FOR THE REMOTE, AND SLIPPED OUT OF BED. NO INJURIES WERE REPORTED. (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 HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170270 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM FXI DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1