BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALS

    MDR report key: 727086 · Received June 19, 2006

    Report

    Report Number
    2132280-2006-00001
    Event Type
    Injury
    Date Received
    June 19, 2006
    Date of Event
    June 6, 2006
    Report Date
    June 6, 2006
    Manufacturer
    SUNRISE MACHINE AND TOOL, PROFESSIONAL ASSISTANCE LIFT
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    IA

    Narratives

    Additional Manufacturer Narrative · 1

    WE UNDERSTOOD FROM THE EVENT DESCRIPTION THAT NOTHING WAS BROKEN. THE UNIT IS 6 1/2 YRS OLD AND IT SEEMS THAT DURING MAINTENANCE INSPECTIONS, THESE 2 BOLTS WERE OVERLOOKED FOR TIGHTNESS, CAUSING THE 4 POINT HANGER TO COME OFF, ANY MECHANICAL DEVICES OF THIS AGE MUST BE CHECKED FROM TOP TO BOTTOM FOR WEAR AND LOSE PARTS AT REGULAR INTERVALS.

    Description of Event or Problem · 1

    RESIDENT BEING TRANSFERRED VIA FULL BODY LIFT FROM BED TO WHEELCHAIR WITH 2 CNAS IN ATTENDANCE. RESIDENT FELL FROM LIFT, FROM APPROX 4FT. IN AIR, TO LAND ON FLOOR WHEN ARMS CAME OFF NECK OF LIFT. BOTH BOLTS + ENTIRE 4 POINT ARMS ON FLOOR, NO SIGN OF LOOSENING OR BREAKAGE OF BOLTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALS 4 PT. LIFT (FULL BODY) FSA SUNRISE MACHINE AND TOOL, PROFESSIONAL ASSISTANCE LIFT PC 4504

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization