BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOCARDIOGRAPH DEVICE

    MDR report key: 31320 · Received March 19, 1996

    Report

    Report Number
    MW1008670
    Event Type
    Malfunction
    Date Received
    March 19, 1996
    Report Date
    March 19, 1996
    Manufacturer
    UNKNOWN
    Product Code
    DXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    RPTR WORKED AS AN INDEPENDANT CONTRACTOR FOR A BUSINESSMAN. RPTR WENT TO VARIOUS DOCTORS' OFFICES TO PERFORM DIAGNOSTIC TESTS. THE BUSINESSMAN DID THE BILLING FOR THE SERVICES. THE EQUIPMENT USED WAS FAULTY. DURING THE EXAM HIS MACHINE DID NOT HAVE COLOR AND THE DOPPLER STOPPED WORKING. BUSINESSMAN STILL BILLED PTS FOR SERVICES THAT THE CUSTOMERS DID NOT GET. HE ORDERED TESTS THAT WERE NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOCARDIOGRAPH DEVICE ECHOCARDIOGRAPH DXK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *