BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI380

    MDR report key: 4835052 · Received June 1, 2015

    Report

    Report Number
    2183461-2015-00002
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    PMA / PMN Number
    K142105
    Removal / Correction Number
    2183461-05/27/15-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS OPENED TO DOCUMENT INVESTIGATION AND CORRECTIVE ACTION FOR THIS ISSUE. MORTARA INSTRUMENT, INC HAS RECENTLY BECOME AWARE OF A POTENTIAL SAFETY HAZARD INVOLVING OUR ELI 380 ELECTROCARDIOGRAPH. WHEN USED IN THE WORKFLOW DESCRIBED BELOW, ACQUIRED ECG WAVEFORMS FOR ONE PT MAY BECOME ASSOCIATED WITH THE PT DEMOGRAPHICS FOR A DIFFERENT PT WHEN THE RECORD IS TRANSMITTED TO A RECORDS MANAGEMENT SYSTEM. A HAZARDOUS SITUATION MAY BE CREATED WHEN THE FOLLOWING WORKFLOW IS USED: ECGS ARE ORDERED VIA AN EXTERNAL RECORDS MANAGEMENT SYSTEM. AN ORDER LIST IS DOWNLOADED TO THE ELI 380 ELECTROCARDIOGRAPH. AN ECG TECHNICIAN SELECTS AN ORDER FROM THE LIST IN THE ELI 380, LOCATES THE PT, ACQUIRES AND STORES THE ECG RECORD ON THE ELI 380. A NEW ORDER LIST IS SUBSEQUENTLY DOWNLOADED TO THE SAME ELI 380 AND THE NEW ORDER LIST DIFFERS FROM THE PREVIOUS ORDER LIST. AN ECG ASSOCIATED WITH THE ORIGINAL ORDER LIST IS RETRIEVED FROM MEMORY, EDITED AND STORED AGAIN. THE ECG RECORD IS TRANSMITTED TO THE RECORDS MANAGEMENT SYSTEM TO FULFILL THE ORDER. IN THIS WORKFLOW, EDITING AND SAVING THE RECORD IN STEP 5 MAY RESULT IN A WRONG ORDER NUMBER BECOMING ASSOCIATED WITH THE ECG RECORD IN THE ELI 380. WHEN THE ECG RECORD IS TRANSMITTED TO THE RECORDS MANAGEMENT SYSTEM TO FULFILL THE ORDER, THE INCORRECT ORDER NUMBER MAY CAUSE THE RECEIVING SYSTEM TO ASSOCIATE THE ACQUIRED ECG WAVEFORMS WITH THE WRONG PT DEMOGRAPHICS. THUS, WHEN VIEWED ON THE RECORDS MANAGEMENT SYSTEM, THE ECG MAY SHOW THE DEMOGRAPHICS FOR PT A, BUT THE ECG WAVEFORMS FOR PT B. THIS PROBLEM ONLY OCCURS WHEN USING THE ELI 380 IN AN ORDERS-DRIVEN ENVIRONMENT. RECORDS WITH MISMATCHED ECG WAVEFORMS AND PT DEMOGRAPHICS ONLY APPEAR ON THE RECORDS MANAGEMENT SYSTEM AFTER BEING RECEIVED FROM THE ELI 380. WHEN VIEWED OR PRINTED ON THE ELI 380 ITSELF, ECG WAVEFORMS AND PT DEMOGRAPHICS ARE ALWAYS MATCHED PROPERLY. A CORRECTION HAS BEEN DEVELOPED TO ELIMINATE THE IDENTIFIED POTENTIAL RISK. THE CORRECTION REQUIRES THE ELI 380 SYSTEM SOFTWARE TO BE UPGRADED TO VERSION 1.1.1. THIS NEW VERSION OF SOFTWARE CORRECTS THE HANDLING OF ORDER NUMBERS TO ENSURE THE CORRECT ORDER NUMBER IS ASSOCIATED WITH THE CORRECT ECG, REGARDLESS OF THE WORKFLOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SPECIFIC PT ECG COULD NOT BE LOCATED IN THEIR EMR SYSTEM. THEY LOCATED THE PRINTED RECORD WITH THE CORRECT PT INFO WRITTEN TO THE RECORD. THEY SEARCHED THEIR EMR SYSTEM FOR THE ACQUISITION TIME OF THE RECORD AND FOUND A DIFFERENT PT'S DEMOGRAPHIC INFO ATTACHED TO THE SAME WAVEFORM OF THE ACTUAL PT. THIS HAS BEEN OBSERVED FOUR TIMES ON TWO DIFFERENT ELI380 CARTS/ THE CUSTOMER MANUALLY LOCATED THE MISMATCHED RECORDS, CORRECTED THE DEMOGRAPHIC INFO, AND SAVED THE RECORDS. NO PT INJURY OR MISDIAGNOSES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354136 ELI380 ELI380 DPS MORTARA INSTRUMENT, INC. ELI380-ACX11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA