BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHASTAR

    MDR report key: 728585 · Received June 16, 2006

    Report

    Report Number
    8010652-2006-00005
    Event Type
    Other
    Date Received
    June 16, 2006
    Report Date
    April 28, 2006
    Manufacturer
    MAQUET GMBH AND CO KG
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE SITUATION THE USER DID NOT HAVE THE HEAD SECTION PROPERLY ATTACHED TO THE TABLE. CUSTOMER IS UNWILLING TO PROVIDE SERIAL NUMBER OF TABLE INVOLVED. DURING PREVIOUS EVAL AT THIS FACILITY 50% OF THE TABLES WERE FOUND TO HAVE AT LEAST 1 OF THE HEAD REST LOCK KNOBS LOOSE OR NOT ENGAGED TO THE HEAD REST.

    Description of Event or Problem · 1

    WHILE POSITIONING A PT IN THE OR THE HEAD SECTION CAME OFF OF THE TABLE AND THE PTS HEAD JERKED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHASTAR OR TABLE FQO MAQUET GMBH AND CO KG 1132 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR