BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SRIBE

    MDR report key: 2480035 · Received March 1, 2012

    Report

    Report Number
    2480035
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    DURING THE COOL DOWN PERIOD OF A CARDIAC STRESS TEST, THE PHYSIOLOGIC MONITOR STOPPED FUNCTIONING, LOSING ALL TEST DATA AND ELIMINATING THE ABILITY TO CONTINUE MONITORING THE PATIENT'S STATUS. THIS IS THE FOURTH TIME THAT THIS HAS HAPPENED IN RECENT MONTHS ON THREE DIFFERENT STRESS TEST MACHINES AT TWO DIFFERENT FACILITIES. AT LEAST A COUPLE OF TIMES THE PROBLEM HAS BEEN NOTED TO OCCUR WHEN THE ECG F11 OPTION IS SELECTED WITH THE MOUSE DURING THE BRUCE PROTOCOL.======================MANUFACTURER RESPONSE FOR STRESS EXERCISE SYSTEM, X-SCRIBE (PER SITE REPORTER).======================NO RESPONSE AS YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SRIBE STRESS EXCERCISE SYSTEM DSI MORTARA INSTRUMENT, INC. X-SCRIBE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *