BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMD

    MDR report key: 448629 · Received February 16, 2003

    Report

    Report Number
    9616576-2003-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2003
    Date of Event
    December 30, 2002
    Report Date
    February 12, 2003
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOR THE CARDIOMD PRODUCT IN QUESTION DDD HAS DISCOVERED PROBLEMS WITH THE ACCURACY OF DETECTOR POSITIONING. THIS CAN OVER TIME RESULT IN ARTIFACTS IN RE-CONSTRUCTED IMAGES, AND HAS IN ONE CASE RESULTED IN MIS-DIAGNOSIS - (THE INCIDENT). ON THE INCIDENT SITE THE QC PROCEDURES HAVE BEEN PERFORMED ON A WEEKLY BASIS AS DESCRIBED IN THE OPERATORS MANUAL - (SYSTEM OUT OF CALIBRATION). THIS IN COMBINATION WITH THE PRODUCT PROBLEM, THAT SEEMS TO BE A BUILDING UP OF DETECTOR POSITIONING ERRORS OVER TIME, HAS PROVIDED BASIS FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOMD NUCLEAR MEDICINE EQUIPMENT KPS DANISH DIAGNOSTIC DEVELOPMENT A/S 9CSY0799-C03 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *