BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENOR

    MDR report key: 1952887 · Received December 2, 2010

    Report

    Report Number
    3004468271-2010-00041
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM THE BED TO A WHEEL CHAIR. STNA MOVED THE WHEEL CHAIR SIDEWAYS TO THE LIFT WITH THE LEGS STILL CLOSED AND STARTED LOWERING HIM. AS THEY WERE LOWERING ONE STNA WAS PULLING THE RESIDENT TO ALIGN HIM WITH THE CHAIR AND THE LIFT TIPPED OVER SIDEWAYS AND THE JIB ON THE LIFT HIT HIM IN THE FOREHEAD. THE HANGER BAR ALSO HIT ONE OF THE STNAS IN THE HEAD AND THE LEFT LEG OF THE LIFT HIT THE OTHER STNA IN THE SHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR PASSIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV KHA1010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other