BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS

    MDR report key: 2355901 · Received December 1, 2011

    Report

    Report Number
    2355901
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 23, 2011
    Manufacturer
    MORTARA INTSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO EMERGENCY DEPARTMENT (ED) W/ AFIB WITH HISTORY OF VTACH.ELI 350 ELECTROCARDIOGRAPH WAS TURNED ON, AND THE PATIENT 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 PATIENT WAVEFORM. THE WAM ICON DISPLAYED "3 BARS" OF SIGNAL AND A 'GOOD' BATTERY'. STAFF WENT BACK TO THE PATIENT 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, PATIENT 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 PATIENT AND POWERED THE WAM 'OFF' THEN BACK 'ON'. WE NOW HAD, AT 14:29, AN EKG WAVEFORM AND NEEDED TO PUT THE PATIENT DATA IN. THE TOTAL ELAPSED TIME WAS 11 MINUTES. "DOOR TO EKG" TIME IS A REQUIRED 10 MINUTES FOR MI.======================MANUFACTURER RESPONSE FOR ELECTROCARDIOGRAPH, ELI 350 (PER SITE REPORTER).======================MFG WILL EVALUATE THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR