BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE

    MDR report key: 1697498 · Received May 19, 2010

    Report

    Report Number
    MW5016035
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    September 29, 2007
    Report Date
    May 19, 2010
    Manufacturer
    MORTARA INSTRUMENTS
    Product Code
    LOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MR. (B) (6) WAS A (B) (6) MALE WITH NO PRIOR HISTORY OF CARDIOVASCULAR DISEASE, WHO WAS SEEN BY HIS FAMILY PRACTICE PHYSICIAN ON THE MORNING OF (B) (6) 2007 FOR COMPLAINTS OF SHARP BACK PAIN. VITAL SIGNS WERE NORMAL WITH A HEART RATE OF 64 BEATS PER MINUTE. AN ELECTROCARDIOGRAM - ECG - WAS ORDERED USING A MORTARA INSTRUMENTS ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE. THE FIRST ECG SHOWED ONLY EXCESSIVE MOVEMENT ARTIFACT. A SECOND ECG WAS OBTAINED WITH NO MOVEMENT OR ARTIFACT AND THIS ECG INTERPRETATION PRINTED "WOLFF-PARKINSON-WHITE TYPE B" - DESPITE SEVERE ST SEGMENT ELEVATION PRESENT IN ALL PRE-CORDIAL LEADS-. A THIRD ECG ORDERED AND DESPITE HAVING BOTH 2MM AND 3MM ST SEGMENT ELEVATIONS PRESENT IN THE ANTERIOR-LATERAL LEADS, PRINTED ONLY AN INTERPRETATION OF: "WOLFF-PARKINSON-WHITE TYPE B". THE PT WAS DISCHARGED WITH FOLLOW UP SCHEDULED FOR A NEW DIAGNOSIS OF "WOLFF-PARKINSON-WHITE TYPE B" HOWEVER, THE PT DIED BEFORE HIS APPOINTMENT. AUTOPSY REVEALED HE DIED OF A MASSIVE ANTERO-LATERAL MYOCARDIAL INFARCTION. SINCE THIS PT DEATH, OUR ENGINEERS HAVE STUDIED THIS PARTICULAR ELECTROCARDIOGRAPH MACHINES INTERPRETIVE ALGORITHM AND HAVE FOUND EVIDENCE OF A CRUCIAL ERROR IN THE DESIGN OF THE INTERPRETIVE ALGORITHM. WE HAVE ALSO DISCOVERED SERIOUS AND FAULTY INTERPRETIVE CRITERIA FOR THE ALGORITHMS DIAGNOSIS OF WOLFF-PARKINSON-WHITE TYPE A AND B. DATES OF USE: (B) (6) 2007 - (B) (6) 2007. DIAGNOSIS OR REASON FOR USE: ACUTE SHARP BACK PAIN, SHORTNESS OF BREATH, DIZZINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE INTERPRETIVE ELECTROCARDIOGRAPH MACHINE LOS MORTARA INSTRUMENTS ELI 200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death