BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEIDELBERG RETINA ANGIOGRAPH

    MDR report key: 440195 · Received January 14, 2003

    Report

    Report Number
    8043762-2003-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2003
    Date of Event
    December 12, 2002
    Report Date
    January 7, 2003
    Manufacturer
    HEIDELBERG ENGINEERING
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOTH SCANNING MIRRORS OF THE DEVICE STOPPED MOVEMENT AND THE LASER BEAM WAS NOT SWITCHED OFF BY THE LASER SAFETY CIRCUIT. WHEN THE FAILURE OCCURRED, NO PATIENT WAS EXAMINED AND NO PERSON WAS EXPOSED TO LASER RADIATION. THE PHYSICIANS AND SPECIALISTS FOR HEIDELBERG RETINA ANGIOGRAPH (HRA/C) DEVICE EXAMINATIONS IMMEDIATELY RECOGNIZED THE FAILURE WHEN THEY SWITCHED ON THE DEVICE, AND CALLED THE HEIDELBERG ENGINEERING SUPPORT HOTLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEIDELBERG RETINA ANGIOGRAPH HRA/C IZI HEIDELBERG ENGINEERING HRA/C *

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability