BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 9136817 · Received September 30, 2019

    Report

    Report Number
    3009402404-2019-00064
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 20, 2019
    Report Date
    September 30, 2019
    Manufacturer
    FXI
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, THE PATIENT FELL OFF THE BED ON 2 OCCASIONS. ON (B)(6) 2019, THE PATIENT WAS FOUND ROLLED UP IN A BLANKET ON THE RIGHT SIDE OF THE BED. THE PATIENT SUSTAINED A SKIN TEAR ON THE LEFT ELBOW THAT WAS ADDRESSED AT THE FACILITY. ON (B)(6) 2019, THE PATIENT WAS FOUND ON THE LEFT SIDE OF THE BED ON THE FLOOR. THE PATIENT DID NOT SUSTAIN ANY INJURIES. 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 HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931840 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS FNM FXI DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR