BEUDAMED
    FDA Adverse Event Summary report: N

    VERITAS

    MDR report key: 2404606 · Received December 23, 2011

    Report

    Report Number
    2183461-2011-00001
    Date Received
    December 23, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 23, 2011
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    PMA / PMN Number
    K082946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE REPAIR ORDER WAS OPENED ON (B)(4) 2011, FOR THE RETURN AND EVAL OF THE ELI 350 ELECTROCARDIOGRAPH AND WAM PT CABLE. THE ELI 350 ELECTROCARDIOGRAPH WAS EVALUATED ON (B)(4) 2011, AND THE REPORTED INCIDENT COULD NOT BE REPRODUCED. THE TECH COULD NOT REPRODUCE ANY PRINTING ERRORS AND WAS ABLE TO PRINT NUMEROUS PAGES WITHOUT ANY ISSUE. THE PRINT CUE SENSOR VOLTAGE WAS MEASURED AND FOUND TO BE WITHIN SPECS. THE WAM PT CABLE WAS ALSO EVALUATED ON (B)(4) 2011, AND THE REPORTED INCIDENT COULD NOT BE REPRODUCED. THE TECH COULD PAIR THE WAM AND COULD NOT REPRODUCE ANY OF THE REPORTED ISSUES. THE ELECTROCARDIOGRAPH WAS EVALUATED TO THE MORTARA INSTRUMENT SPEC DOCUMENTS AND SAFETY TESTING AND PASSED ALL TESTS. THE ELI 350 ELECTROCARDIOGRAPH AND WAM PT CABLE WERE THEN PACKAGED AND RETURNED TO TUALITY HEALTHCARE ON (B)(4) 2011. REVIEW OF THE DEVICE HISTORY RECORD FOR ELI 350 ELECTROCARDIOGRAPH, SERIAL NUMBER: (B)(4), INDICATED NO ISSUES OBSERVED DURING MFG.

    Description of Event or Problem · 1

    EVENT DESC: PT ADMITTED TO EMERGENCY DEPT (ED) WITH A-FIB (ATRIAL FIBRILLATION) WITH HISTORY OF V-TACH (VENTRICULAR TACHYCARDIA). ELI 350 ELECTROCARDIOGRAPH WAS TURNED ON, AND THE PT DATA ENTERED; STAFF APPLIED ELECTRODES, HOOKED UP AND TURNED ON THE WAM (WIRELESS MODULE). STAFF THEN WENT BACK TO THE MACHINE, APPROX 15 FEET AWAY, TO FIND THE DISPLAY SHOWING "SQUARE WAVES" ONSCREEN: MEANING; IT SEES THE WAM BUT NOT THE PT WAVEFORM. THE WAM ICON DISPLAYED "3 BARS" OF SIGNAL AND A 'GOOD' BATTERY'. STAFF WENT BACK TO THE PT TO CHECK CONNECTIONS AND SAW AN AMBER LIGHT ON THE WAM; SO POWERED IT 'OFF', THEN BACK 'ON.' THE WAM LED WAS NOW GREEN. WHEN STAFF WENT BACK TO THE MACHINE AT 14:18:14, THE PRINTER WAS PRINTING "SQUARE WAVES" NOT EKG RHYTHMS. THE STAFF DID NOT HIT THE PRINT BUTTON. THE PRINTER WAS 'ON' AND THERE WERE 'NO OPTIONS' TO STOP IT. THE DISPLAY SHOWED: 1) THE NORMAL 'ACQUIRE EKG SCREEN' BUT WAS SHOWING "SQUARE WAVES", 2) THE PRINTER WAS RUNNING AND WON'T SHUT OFF, NO OPTION TO STOP. THE STAFF HIT THE POWER BUTTON ONCE TO STOP THE PRINTER, THE DISPLAY SCREEN WENT TO THE "LOGO" PAGE AND FROZE/LOCKED UP AND THEY WERE UNABLE TO TURN OFF THE MACHINE BY CLOSING AND OPENING THE LID. THE SCREEN STAYED FROZEN FOR ABOUT 5 MINUTES. THE MACHINE WAS STILL CONNECTED TO THE WAM, THE GREEN WAM LED MAINTAINED THROUGHOUT, UNTIL BIOMED USED THE 7 SECOND POWER DOWN. BIOMED POWERED BACK UP, PT DATA WAS GONE, BUT "SQUARE WAVES" WERE STILL ON THE SCREEN UNTIL THE "SETTINGS" WERE CHANGED FROM 'WAM' TO A 'DIRECT CABLE' THEN BACK TO 'WAM'. STAFF THEN WENT TO THE PT AND POWERED THE WAM 'OFF' THEN BACK 'ON.' WE NOW HAD, AT 14:29, AN EKG WAVEFORM AND NEEDED TO PUT THE PT DATA IN. THE TOTAL ELAPSED TIME WAS 11 MINUTES. "DOOR TO EKG" TIME IS A REQUIRED 10 MINUTES FOR MI (MYOCARDIAL INFARCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC. ELI 350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other