BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARDIAMOBILE

    MDR report key: 9782689 · Received March 3, 2020

    Report

    Report Number
    3009715978-2020-00001
    Event Type
    Injury
    Date Received
    March 3, 2020
    Report Date
    February 4, 2020
    Manufacturer
    ALIVECOR, INC.
    Product Code
    DPS
    PMA / PMN Number
    K182396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALIVECOR RECEIVED A COMPLAINT FROM USER'S RELATIVE WHERE IT APPEARS THAT THE USER WHILE EXPERIENCING A HEART ATTACK RECORDED AN ECG AND LIKELY RECEIVED DEVICE ALGORITHM ANALYSIS OF "NORMAL SINUS RHYTHM". IT IS UNKNOWN WHETHER THE USER DELAYED SEEKING MEDICAL ATTENTION DUE TO THE KARDIAMOBILE RESULT. ALIVECOR FOLLOWED UP WITH THE USER 4 SEPERATE TIMES TO GET ADDITIONAL INFORMATION BUT WAS NOT SUCCESSFUL. ALIVECOR IS A LEAD-I MOBILE ECG THAT IS NOT INTENDED TO DETECT HEART ATTACKS. THE DEVICE LABELING SPECIFIES THAT THE DEVICE DOES NOT DETECT HEART ATTACK. IT IS POSSIBLE FOR ECGS DURING A HEART ATTACK TO STILL BE NORMAL SINUS RHYTHM. 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

    PATIENT'S FAMILY MEMBER CONTACTED ALIVECOR STATING THAT THE PATIENT USED KARDIAMOBILE TO TAKE EKG AND RECEIVED NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENT FROM THE PATIENT'S FAMILY MEMBER NOTES THAT "...WE FOUND OUT IT (KARDIAMOBILE) WAS DEFECTIVE WHEN MY MOM USED THE PRODUCT AND IT SHOWED NORMAL AS SHE WAS IN THE MIDDLE OF A HEART ATTACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245357 KARDIAMOBILE MOBILE ELECTROCARDIOGRAM DPS ALIVECOR, INC. AC-009

    Patients

    Seq Age Sex Outcome Treatment
    1