BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXI MOVE

    MDR report key: 2311362 · Received October 4, 2011

    Report

    Report Number
    9681684-2011-00068
    Event Type
    Other
    Date Received
    October 4, 2011
    Date of Event
    September 8, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED BY FACILITY STAFF: WHILE NURSES AID WAS TRANSPORTING RESIDENT FROM BED TO CHAIR, THE RIGHT FOOT SIDE SLING CLIP CAME DETACHED AND RESIDENT HAD TO BE SUPPORTED BY NURSES AID TO PREVENT RESIDENT FROM FALLING TO GROUND WHILE LIFT WAS LOWERED TO FLOOR. NO INJURIES REPORTED. THE SLING INVOLVED IN THE INCIDENT IS IN EXCELLENT CONDITION, HOWEVER THE LIFT FRAME LUGS APPEAR TO BE TOO SMALL FOR PROPER SECURING ACCORDING TO THE ARJOHUNTLEIGH REP WHO WENT ON-SITE SHORTLY AFTER THE EVENT. THE SLING INVOLVED IN INCIDENT WAS TESTED ON MULTIPLE (8) OTHER SIMILAR UNITS. THE SYS INVOLVED WAS THE ONLY ONE WHICH THE SLING CLIP LUGS APPEARED TO BE TOO SMALL FOR PROPER SECURING. THE SYS HAS BEEN TAKEN OUT OF USE AND SVC RECOMMENDS REPLACING THE SYS LIFT FRAME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR