BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SCRIBE

    MDR report key: 252750 · Received December 2, 1999

    Report

    Report Number
    2183461-1999-00001
    Event Type
    Malfunction
    Date Received
    December 2, 1999
    Date of Event
    November 4, 1999
    Report Date
    November 19, 1999
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ROUTINE STRESS EXERCISE PROCEDURE IN A HOSP CLINICAL SETTING. THIS IS A CLINICALLY ATTENDED PROCEDURE USING A PROTOCOL, A MORTARA X-SCRIBE MONITOR, AND A TREADMILL. TREADMILL RESPONDED INCORRECTLY TO SPEED/ELEVATION COMMANDS FROM THE X-SCRIBE AND THEN DID NOT RESPOND TO STOP COMMANDS FROM X-SCRIBE. THE INCORRECT RESPONSE RESULTED IN INCREASING ACCELERATION BY THE TREADMILL. THE ATTENDING CLINICIAN USED THE EMERGENCY STOP BUTTON ON THE TREADMILL WHICH HALTED TREADMILL ACTIVITY. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SCRIBE STRESS EXERCISE MONITORING DPS MORTARA INSTRUMENT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other