BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 7827171 · Received August 29, 2018

    Report

    Report Number
    3009402404-2018-00057
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 29, 2018
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT INVOLVED: GENDRON MAXIREST BED. GENDRON, INC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "SHE STARTED THERE IS NOTHING WRONG WITH THE EQUIPMENT. IT WAS THE WAY IT IS SET UP AND THAT THE DFLAL, WHEN INFLATED, RISES TO ABOUT 1 1/2 " FOR THE TOP OF THE RAILS. SHE BELIEVES THAT IS WHY HE FELL OUT BECAUSE THE RAILS ARE NOT TALL ENOUGH. THE PATIENT WAS NOT INJURED AND SOUGHT NO MEDICAL ATTENTION AFTER THE FALL." COMPLAINT (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
    667638 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS, FNM FXI DFLAL-4280-M

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR