BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAAPPHIRE SERIES PULSE MATTRESS REPLACEMENT SYSTEM

    MDR report key: 2840532 · Received October 8, 2012

    Report

    Report Number
    2840532
    Event Type
    Injury
    Date Received
    October 8, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 3, 2012
    Manufacturer
    SUNFLOWER MEDICAL LLC
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANT TURNED RESIDENT ON SIDE TO PROVIDE CURE. RESIDENT STARTED TO ROLL OFF BED AND NURSING ASSISTANT COULD NOT STOP THE RESIDENT FROM FALLING. THE FALL RESULTED IN A FRACTURED FEMUR. FACIAL HEAD CONTUSION, NASAL FOREHEAD ABRASION. I DO NOT BELIEVE THIS A MEDICAL DEVICE FAILURE. WE HAVE USED THIS PRODUCT FOR MANY RESIDENTS FOR MANY YEARS WITHOUT INCIDENT. I AM FILING THIS REPORT ONLY BECAUSE THE MATTRESS WAS IN USE AT THE TIME OF THE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAAPPHIRE SERIES PULSE MATTRESS REPLACEMENT SYSTEM AIR MATTRESS INX SUNFLOWER MEDICAL LLC GLOBAL 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization