BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 2223531 · Received July 21, 2011

    Report

    Report Number
    9681684-2011-00052
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RESIDENT WAS SEATED IN WHEELCHAIR WHILE TWO STAFF MEMBERS ATTEMPTED TO TRANSFER HIM FROM CHAIR TO BED. THE SLING WAS APPLIED AND RESIDENT ROSE TO APPROX SHOULDER HEIGHT OF THE STAFF. THEN, THE LEFT LEG SLING CLIP BECAME LOOSE ON KNOB, RESIDENT LEANED TO LEFT SIDE AND FELL OUT OF SLING TO THE FLOOR. PHYSICIAN EXAMINED AND TREATED THE RESIDENT FOR CONTUSION AND BUMP ON HEAD. THE RESIDENT WAS RELEASED FROM HOSPITAL AND RETURNED TO FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other