BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET, MOBILE O.R. TABLE, ALPHASTAR

    MDR report key: 3952406 · Received March 5, 2014

    Report

    Report Number
    3008355164-2014-00044
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 5, 2014
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITH A PATIENT ON THE TABLE TOP, BOTH LEG SECTIONS (REVERSE BACK) OF THE DEVICE BROKE AT THE PIVOT POINT. THE PATIENT SLID OUT OF POSITION BUT REMAINED ON THE TABLE. PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT REPORTED. (B)(4). MFR - 8010652-2014-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132968 MAQUET, MOBILE O.R. TABLE, ALPHASTAR TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 1132.1382 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI