BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARDIAMOBILE

    MDR report key: 10217486 · Received July 1, 2020

    Report

    Report Number
    3009715978-2020-00003
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ALIVECOR, INC.
    Product Code
    DXH
    UDI-DI
    B210AC0090
    PMA / PMN Number
    K191406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER CONTACTED ALIVECOR ON (B)(6) 2020 ABOUT A COMPLAINT REGARDING HIS KARDIAMOBILE 1L DEVICE WHILE EXPERIENCING A HEART ATTACK ON (B)(6) 2020. USER RECORDED AN EKG ON HIS KARDIAMOBILE 1L AND RECEIVED A DEVICE ALGORITHM ANALYSIS OF "NORMAL SINUS RHYTHM". THE USER DID NOT DELAY SEEKING MEDICAL ATTENTION DUE TO THE KARDIAMOBILE RESULT. ALIVECOR CONTACTED THE USER ON FOUR SEPARATE OCCASIONS (JUNE 5, JUNE 9, JUNE 17 AND JUNE 19) TO INVESTIGATE THE COMPLAINT AND RETRIEVE EKG DATA FOR CARDIOLOGY REVIEW HOWEVER THE USER DID NOT SEND HIS EKG TRACING. ALIVECOR'S KARDIAMOBILE 1L DEVICE IS A LEAD-I MOBILE EKG DEVICE THAT IS NOT INTENDED TO DETECT AN INFARCT OR ST ELEVATION. THE DEVICE LABELING SPECIFIES THAT THE DEVICE DOES NOT DETECT HEART ATTACKS. IT APPEARS THAT THE DEVICE LIKELY HAD NO MALFUNCTION, DID NOT CAUSE OR CONTRIBUTE TO THE HEART ATTACK, AND THE INCIDENT WAS A RESULT OF USER ERROR.

    Description of Event or Problem · 1

    USER CONTACTED ALIVECOR ON (B)(6) 2020 STATING THAT HE USED HIS KARDIAMOBILE 1L TO TAKE AN EKG AND RECEIVED A NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENTS FROM THE PATIENT NOTES THAT "STILL RECOVERING FROM HEART ATTACK ON (B)(6). I USED THIS DEVICE 2 MINUTES PRIOR TO CALLING AMBULANCE AND DEVICE SAID EVERYTHING WAS FINE WITH MY HEART. SUFFERED MAJOR HEART ATTACK THAT MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683645 KARDIAMOBILE MOBILE ELECTROCARDIOGRAM DXH ALIVECOR, INC. AC-009 B210AC0090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization