BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI 500

    MDR report key: 3763215 · Received April 15, 2014

    Report

    Report Number
    1419652-2014-00104
    Event Type
    Death
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT'S TRANSFER WITH THE MAXI 500 LIFT AND THE CLIP SLING THE RESIDENT FELL OUT OF THE SLING AND SUSTAINED AN INJURY. AFTER THREE WEEKS WE RECEIVED ADDITIONAL DETAILS RELATED TO THE INCIDENT. ALL INFORMATION WAS DOCUMENTED IN AN INCIDENT DESCRIPTION FORM BY AN ARJOHUNTLEIGH REPRESENTATIVE WHO VISITED THE CUSTOMER SITE. IN ACCORDANCE TO INFORMATION PROVIDED DURING THE RESIDENT'S TRANSFER FROM THE BED TO THE WHEELCHAIR ONE OF THE GREY CLIP OF THE SLING DETACHED FROM THE LUG ON THE LEFT SIDE OF THE HANGER BAR CAUSING THE PT TO FALL TO THE FLOOR HITTING THE HEAD. THE PT INVOLVED IN THE INCIDENT WAS A FEMALE AND RECEIVED SKULL FRACTURE AND HEAD INJURIES AS A CONSEQUENCE OF THE EVENT. ARJOHUNTLEIGH HAS BEEN INFORMED THAT THE PT DIED AFTER 3 DAYS AFTER THE INCIDENT OCCURRED. REFERENCE NUMBER MFR 9681684-2014-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229198 MAXI 500 FSA ARJOHUNTLEIGH MAGOG, INC. KM560181

    Patients

    Seq Age Sex Outcome Treatment
    1 Death