BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL

    MDR report key: 6079899 · Received November 4, 2016

    Report

    Report Number
    3009402404-2016-00041
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 4, 2016
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND ANY RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE, ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, WOUND NURSE WENT INTO THE ROOM AND THE MATTRESS WAS DEFLATED. THE PATIENT WAS LYING ON HIS SIDE. THE PATIENT HAS A TRACHEA AND CANNOT MOVE BY HIMSELF. THE MATTRESS WAS SLIGHTLY COVERING THE TRACHEA SO THE PATIENT COULD NOT TAKE FULL BREATHS. ADDITIONALLY, WHEN THE MATTRESS DEFLATED, DURING NUMEROUS OCCASIONS, THIS CAUSED BEDSORES ON THE PATIENTS' TAILBONE. THE FACILITY HAS TAPPED THE HOSE ASSEMBLY BACK TOGETHER AND IS CONTINUING TO USE UNDER THE RESIDENT. THE BEDSORES WERE TREATED AT THE FACILITY. 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
    729302 DERMAFLOAT LAL PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DFLAL-3680-M

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR