BEUDAMED
    FDA Adverse Event Summary report: N

    NONE

    MDR report key: 2740757 · Received April 13, 2012

    Report

    Report Number
    2183461-2012-00001
    Date Received
    April 13, 2012
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    PMA / PMN Number
    K022618
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REP X-SCRIBE SYSTEM WAS UTILIZED TO ATTEMPT TO REPRODUCE THE REPORTED INCIDENT FROM THE REPORT. THE STANDARD BRUCE PROTOCOL TEST WAS CONFIGURED FOR EXERCISE AND RECOVERY WITH A PRINTOUT EVERY 2 MINUTES STARTING AT 1 MINUTES. THE EXAM WAS CONDUCTED FOR AN EXTENDED TIMEFRAME TO SEE IF EXCEEDING THE DESIGNED DATA STORAGE LIMIT OF 2 HOURS MAY HAVE RESULTED IN THE EXPERIENCED INCIDENT. DURING THE EXAM THE SYSTEM RECORDED THE REQUIRED/REQUESTED ECGS PER THE PROTOCOL AND THE SYSTEM REMAINED IN RECOVERY UNTIL STOPPED BY THE OPERATOR. AFTER EXITING RECOVERY, THE SYSTEM WENT TO THE SUMMARY PAGE WHERE THE EXAM REPORT WAS PRINTED. THE SYSTEM PRINTED ALL THE INFO AS EXPECTED. THE EXAM WAS THEN REVIEWED, IT WAS FOUND THAT THE REVIEW OF THE EXAM WOULD DISPLAY UP TO THE DATA STORAGE LIMIT OF 2 HOURS AND THEN STOPPED, RETURNING TO THE SUMMARY PAGE. WHEN ATTEMPTING TO REVIEW THE EXAM AFTER THIS TIME THE SYSTEM DISPLAYS A MESSAGE "INVALID ARGUMENT TO TIME ENCODE". IN THIS ATTEMPT TO REPRODUCE THE REPORTED EVENT, THE SYSTEM DID NOT FAIL TO DISPLAY, PRINT OR OTHERWISE OPERATE DURING THE EXAM PERIOD. THERE WAS NO LOSS OF THE DATA OR THE EXAM, OR THE ABILITY TO REVIEW THE EXAM AS RECORDED TO THE DATA STORAGE LIMIT OF 2 HOURS IN THE ARCHIVE. THE SUMMARY REPORTS WERE AVAILABLE FOR REPRINT AND REVIEW.

    Description of Event or Problem · 1

    WHAT WAS THE ORIGINAL INTENDED PROCEDURE? A CARDIAC STRESS TEST. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DPS MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1