BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARDIAMOBILE

    MDR report key: 10084224 · Received May 22, 2020

    Report

    Report Number
    3009715978-2020-00002
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 21, 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

    ALIVECOR RECEIVED A COMPLAINT FROM USER/PATIENT WHERE IT APPEARS THAT THE USER WHILE EXPERIENCING A HEART ATTACK RECORDED AN ECG AND RECEIVED DEVICE ALGORITHM ANALYSIS OF "NORMAL SINUS RHYTHM". THE PATIENT DID NOT DELAY SEEKING MEDICAL ATTENTION DUE TO THE KARDIAMOBILE RESULT AND RUSHED TO THE EMERGENCY ROOM. ALIVECOR'S KARDIAMOBILE IS A LEAD-I MOBILE ECG DEVICE THAT IS NOT INTENDED TO DETECT HEART ATTACKS. THE DEVICE LABELING SPECIFIES THAT THE DEVICE DOES NOT DETECT HEART ATTACKS. FOR INVESTIGATION, THE ECG FROM THE USER WAS SENT TO A CARDIOLOGIST FOR REVIEW AND ANALYSIS. THE CARDIOLOGIST CONCURRED WITH KARDIAMOBILE DETERMINATION AND CONFIRMED THAT THE ECG FROM THE USER WAS INDEED IN NORMAL SINUS RHYTHM. BASED ON THE INVESTIGATION RESULTS, ALIVECOR CONCLUDED THAT THE DEVICE HAD NOT MALFUNCTIONED BECAUSE IT PERFORMED AS INTENDED, DID NOT CAUSE OR CONTRIBUTE TO THE HEART ATTACK, AND THE INCIDENT WAS A RESULT OF USER ERROR.

    Description of Event or Problem · 1

    PATIENT CONTACTED ALIVECOR ON (B)(6) 2020 STATING THAT SHE USED KARDIAMOBILE TO TAKE EKG AND RECEIVED NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENTS FROM THE PATIENT NOTES THAT "ON (B)(6), I STARTED HAVING CHEST PAIN, LEFT ARM/SHOULDER PRESSURE/PAIN, NECK AND JAW PAIN. I HAD NOT USED THE KARDIA UNIT IN A WHILE AND HAD TO UPDATE THE APP ON MY PHONE. AFTER MORE THAN FEW ATTEMPTS I GOT A READING THAT SAID NORMAL EKG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546116 KARDIAMOBILE MOBILE ELECTROCARDIOGRAM DXH ALIVECOR, INC. AC-009 B210AC0090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization