BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAFLOAT LAL SYSTEM

    MDR report key: 7598723 · Received June 13, 2018

    Report

    Report Number
    3009402404-2018-00033
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    June 2, 2018
    Report Date
    June 13, 2018
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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, "MATTRESS WAS NOT INFLATING ON ONE SIDE, PATIENT ROLLED OUT OF BED. NO INJURIES REPORTED." COMPLAINT#(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
    439456 DERMAFLOAT LAL SYSTEM PATIENT AIR MATTRESS, FNM JOERNS HEALTHCARE DFLAL-3580-M

    Patients

    Seq Age Sex Outcome Treatment
    1