BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO1 LIFT

    MDR report key: 3035481 · Received June 22, 2006

    Report

    Report Number
    3035481
    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
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    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 EVALUATION. RESIDENT EXPIRED ON (B)(6) 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 LIFT PAL - PROFESSIONAL ASSISTANCE LIFT FNG SUNRISE MACHINE AND TOOL, INC. PC350-84

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention