BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMD

    MDR report key: 597227 · Received June 14, 2004

    Report

    Report Number
    9616576-2004-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2004
    Date of Event
    May 14, 2004
    Report Date
    May 25, 2004
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Product Code
    KPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DETECTOR RADIUSED-IN TOWARDS THE PATIENT. COLLISION DETECTION WAS TRIGGERED AND CEASED ALL MOTIONS. HOWEVER, THE PATIENT EXPRESSED DISCOMFORT AND WAS ADMITTED INTO THE HOSPITAL FOR AN EXAMINATION AND OBSERVATION.

    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 61 YR Hospitalization