BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO1

    MDR report key: 734281 · Received June 22, 2006

    Report

    Report Number
    2132280-2006-00002
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    June 9, 2006
    Report Date
    June 20, 2006
    Manufacturer
    SUNRISE MACHINE AND TOOL, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORDERD 4 POINT HANGERS TO REPLACE THE REQUIRED 2 POINT ON BOTH LIFTS. THESE WERE INSTALLED BY THEIR PEOPLE. OUR REP AND INDEPENDENT TECH INSPECTED THE LIFT IN QUESTION . THEY REPORTED THAT THE NEW POINTS WERE NOT INSTALLED PROPERLY, SEVERAL MAIN ORIGINAL PIECES WERE MISSING, LIKE THE MAIN THRUST BEARING. IN THEIR INVESTIGATION, IT IS THEIR OPINION THAT WHEN THE 4 POINT HANGER WAS INSTALLED MANY OF THE IMPORTANT COMPONENTS WERE NOT USED WHEN REASSEMBLING, THEREFORE THE HANGER ASSEMBLY WAS NOT SAFE, NOR WOULD FUNCTION LIKE IT HAD FOR THE FIRST NINE YEARS. THEIR OPINION IS THAT IF ALL PARTS WOULD HAVE BEEN REPLACED IN THE ORDER THEY CAME FROM THE FACTORY, THIS INCIDENT WOULD NOT HAVE HAPPENED.

    Description of Event or Problem · 1

    RESIDENT BEING TRANSFERRED WITH MECHANICAL LIFT WHEN LIFT FAILED AND RESIDENT FELL TO FLOOR. THE SLING CROSSBAR "SNAPPED" AND DETACHED FROM THE LIFT ARM. RESIDENT COMPLAINED OF LOWER BACK PAIN AND SHORTNESS OF BREATH AND SENT TO HOSPITAL FOR EVAL. RESIDENT EXPIRED IN 2006 AT THE HOSPITAL. STILL UNDETERMINED WHAT ROLE IF ANY THE FALL PLAYED IN CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO1 PAL-PROFESSIONAL ASSISTANCE LIFT FNG SUNRISE MACHINE AND TOOL, INC. PC350-84 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization