BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI 500

    MDR report key: 3030270 · Received March 28, 2013

    Report

    Report Number
    9681684-2013-00025
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOHUNTLEIGH MAGOG INC. ON BEHALF OF THE IMPORTER (B)(6). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR WITH A FLOOR LIFT BY TWO STAFF MEMBERS. THE RESIDENT WAS PLACED ON SLING AND ATTACHED TO THE LIFT. THE LIFT WAS MOVED AND POSITIONED STRADDLING THE LEFT LEG OF THE LIFT. THE STAFF ATTEMPTED TO OPEN THE LIFT LEGS AND LOWER THE LIFT BUT IT DID NOT RESPOND. THE EMERGENCY RELEASE WAS USED. THE LIFT THEN TIPPED TO THE LEFT SIDE TOWARDS THE GROUND. THE RESIDENT LANDED ON THE GROUND, ATTACHED WITH THE SLING WITHOUT THE LIFT/BOOM TOUCHING THE RESIDENT. THEN RESIDENT WAS TRANSPORTED TO THE EMERGENCY ROOM, ADMITTED TO ICU FOR HEAD INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128476 MAXI 500 MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC. KM560181

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization