BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 149700 · Received February 17, 1998

    Report

    Report Number
    2520313-1998-00009
    Event Type
    Malfunction
    Date Received
    February 17, 1998
    Date of Event
    January 20, 1998
    Report Date
    February 15, 1998
    Manufacturer
    F. WALTER HANEL, GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE POST ON THE OVERHEAD MOUNTING POST THAT MOUNTS THE ARM AND INJECTOR HEAD BENT AND EVENTUALLY BROKE. NO INJURY OCCURRED.

    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 * Other