BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 102806 · Received June 30, 1997

    Report

    Report Number
    2520313-1997-00025
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    May 30, 1997
    Report Date
    June 28, 1997
    Manufacturer
    HANEL GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE POSITIONING THE OVERHEAD COUNTERPOISE ARM THE VERTICAL PORTION WHICH 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 HANEL GMBH OCS115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other