BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI MOVE

    MDR report key: 4188481 · Received October 17, 2014

    Report

    Report Number
    9681684-2014-00077
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REP VISITING THE CUSTOMER SITE THAT THE RESIDENT WAS BEING TRANSFERRED FROM THE BRODA CHAIR TO THE BED USING MAXI MOVE PASSIVE LIFT DEVICE. THE STAFF MEMBER COULDN'T FIND A LARGE STANDARD SLING ((B)(4)), THE RESIDENT WAS INSISTENT ON BEING PUT BACK TO BED, SO THAT STAFF USED AN EXTRA-LARGE TOILETING SLING ((B)(4)). THE RESIDENT WAS RAISED UP TO BE TRANSFERRED TO BED AND SLIPPED OUT OF THE SLING HITTING HER HEAD AND HIP ON THE FLOOR. AS A CONSEQUENCE OF THE EVENT THE RESIDENT (AN ELDERLY FEMALE) RECEIVED A SIGNIFICANT SUBDURAL HEMATOMA ON THE BACK OF HEAD AND FRACTURED RIGHT HIP, THEN WAS TAKEN TO THE HOSPITAL. ARJOHUNTLEIGH WAS INFORMED THAT THE RESIDENT DIED AFTER 2 DAYS OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661450 MAXI MOVE FSA ARJOHUNTLEIGH MAGOG INC. KMCSUN-C

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death