BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLPHIN FLUID IMMERSION SYSTEM

    MDR report key: 5025821 · Received August 24, 2015

    Report

    Report Number
    3009402404-2015-00025
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    December 17, 2014
    Report Date
    August 24, 2015
    Manufacturer
    AMERICAN NATIONAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER THE RESIDENT WAS PLACED ON THE MATTRESS ON (B)(6) 2014. HE EXPERIENCED 2 FALLS, ONE ON (B)(6) 2014 AND ONE ON (B)(6) 2015. THERE WERE NO WITNESSES TO EITHER INCIDENT AND IN BOTH CASES THE RESIDENT WAS FOUND ON THE FLOOR BY HIS BED. THE RESIDENT WAS TRANSPORTED TO THE HOSPITAL FOR EVALUATION AND SUSTAINED NO INJURIES. COMPLAINT#(B)(4) AND RA#(B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE DOLPHIN MATTRESS AND CONTROL UNIT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE DOLPHIN MATTRESS AND CONTROL UNIT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557796 DOLPHIN FLUID IMMERSION SYSTEM DOLPHIN SYSTEM FNM AMERICAN NATIONAL DLPH-35820000J-M

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization