BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 2238426 · Received August 15, 2011

    Report

    Report Number
    9681684-2011-00058
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION #1419652) ON BEHALF OF THE MFR BHM MEDICAL, INC (REGISTRATION #96816841). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING A PT TRANSFER FROM BED TO CHAIR, THE STAFF HAD MOVED THE RESIDENT OVER THE CHAIR AND WERE USING THE DPS TO TILT THE RESIDENT FROM A LYING POSITION TO A SEMI SITTING POSITION TO PUT HER INTO A RECLINED CHAIR. AT THIS POINT, THE LEG CLIP FELL OFF AND THE RESIDENT FELL/SLID APPROX 6 INCHES INTO THE CHAIR. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFT FSA BHM MEDICAL, INC. KMCSXN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR