BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 2223481 · Received July 6, 2011

    Report

    Report Number
    9611530-2011-00052
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MANUFACTURER ARJO (B)(4). THE BOLTS THREADED INTO THE PIVOT FRONT END PIECE AND THE THREADS ON THE PIVOT FRONT END PIECE SHOW EXCESSIVE WEAR AND STRIPPING. THE BOLTS THAT THREAD INTO THE PIVOT FRONT END PIECE HAVE EXCESSIVE WEAR. THE PIVOT FRONT END PIECE THREADED HOLES SHOW EXCESSIVE WEAR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM THE BED TO THE COMMODE. THE RESIDENT WAS RAISED FROM THE BED AND THE LIFT MOVED AWAY FROM THE BED APPROXIMATELY A FOOT AND A HALF WHEN THE CAREGIVERS HEARD A CRACKING NOISE COMING FROM THE LIFT. THEY IMMEDIATELY MOVED THE LIFT BACK TOWARD THE BED TRYING TO GET THE RESIDENT OVER THE BED WHEN THE PIVOT FRONT END BOLTS RELEASED CAUSING THE COMPLETE 4 POINT COMBI AND T-BAR TO COME CRASHING DOWN ON THE CAREGIVERS AND RESIDENT. THEY HAD MOVED THE RESIDENT'S BODY HALF WAY OVER THE BED BEFORE BOLTS RELEASED PREVENTING RESIDENT FROM HITTING THE FLOOR AND PREVENTING THE POSSIBILITY OF ANY SERIOUS INJURY. THEY CALLED FOR ASSISTANCE THEN THE 2 CAREGIVERS AND THE RESIDENT WERE TAKEN TO THE ER. BOTH RESIDENT AND CAREGIVERS SUFFERED BRUISES AS A RESULT OF THE INCIDENT, X-RAYS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OSU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O