BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 294813 · Received September 5, 2000

    Report

    Report Number
    2520313-2000-00012
    Event Type
    Malfunction
    Date Received
    September 5, 2000
    Date of Event
    August 18, 2000
    Report Date
    September 1, 2000
    Manufacturer
    F. WALTER HANEL, GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SET SCREWS IN THE MOUNTING COLUMN OF THE CEILING SUPPORT ON THE OVERHEAD COUNTERPOISE SYSTEM BECAME LOOSE, CAUSING THE COLUMN TO SEPARATE AND FALL AND HIT THE CARDIOLOGIST'S RIGHT SHOULDER AND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERHEAD COUNTERPOISE SYSTEM OVERHEAD COUNTERPOISE SYSTEM DXT F. WALTER HANEL, GMBH OCS115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other