BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 149566 · Received February 12, 1998

    Report

    Report Number
    2520313-1998-00008
    Event Type
    Malfunction
    Date Received
    February 12, 1998
    Date of Event
    January 13, 1998
    Report Date
    February 10, 1998
    Manufacturer
    F. WALTER HANLE GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE OVERHEAD COUNTERPOISE ARM THAT MOUNTS THE INJECTOR HEAD FELL. NO INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other