BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLPHIN FLUID IMMERSION SYSTEM

    MDR report key: 5109200 · Received September 28, 2015

    Report

    Report Number
    3009402404-2015-00030
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 28, 2015
    Manufacturer
    AMERICAN NATIONAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    JOERNS SENDING THE REPORT TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER (B)(6) (USER FACILITY) CALLED (B)(6) ((B)(4) OF LONG TERM CARE FOR JOERNS) INFORMING HIM PATIENT HAD FALLEN OUT OF BED AND REQUIRED MEDICAL ATTENTION AT LOCAL HOSPITAL. (B)(6) CALLED CUSTOMER SERVICE TO HAVE DOLPHIN PUMP AND MATTRESS SWAPPED FOR A DFLAL AND EXISTING DOLPHIN PUMP AND MATTRESS PUT IN LOCAL STORAGE ROOM UNTIL COVERLET WOULD BE BROUGHT UP NEXT WEEK. SPOKE WITH (B)(6) (FIELD SERVICE TECHNICIAN) AFTER HE ARRIVED, WAS ON SITE WITHIN AN HOUR AFTER CALL CAME IN AND DID HAS INSTRUCTED BY (B)(6). WILL NOT PUT SAME PRODUCT UNDER PATIENT, WILL PICK UP AND RETURNED TO WAREHOUSE FOR THOROUGH INSPECTION (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE DOLPHIN CONTROL UNIT AND MATTRESS RETURNED TO JOERNS FOR INVESTIGATION. THE DOLPHIN CONTROL UNIT AND MATTRESS WERE RETURNED ON 09/11/2015 AND ARE AWAITING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639503 DOLPHIN FLUID IMMERSION SYSTEM DOLPHIN SYSTEM FNM AMERICAN NATIONAL DLPH-35820000J-M

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization