BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARDIAMOBILE 6L

    MDR report key: 10702303 · Received October 19, 2020

    Report

    Report Number
    3009715978-2020-00004
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 19, 2020
    Manufacturer
    ALIVECOR, INC.
    Product Code
    DXH
    PMA / PMN Number
    K183319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER'S HUSBAND CONTACTED ALIVECOR ON SEPT. 22, 2020 ABOUT A COMPLAINT REGARDING HER KARDIAMOBILE 6L DEVICE. USER'S HUSBAND REPORTED THAT THE USER HAS BEEN USING HER KARDIAMOBILE 6L DEVICE AND READINGS "SHOW UP AS NORMAL". ON (B)(6) 2020, USER SUFFERED CARDIAC ARREST AND SURVIVED. SUBSEQUENTLY, USER'S HUSBAND REPORTED THAT THE USER HAS "LONG QT WHICH WAS THE PRECURSOR" TO THE CARDIAC ARREST. USER AND HER SPOUSE DID NOT UNDERSTAND THAT THE DEVICE ALGORITHM COULD NOT DETECT LONG QT SYNDROME (LQTS) AND MAY HAVE DELAYED SEEKING MEDICAL TREATMENT DUE TO THE KARDIAMOBILE 6L RESULT. ALIVECOR CONTACTED THE USER ON THREE SEPARATE OCCASIONS (OCT. 1, OCT. 9 AND OCT. 15) TO FOLLOW UP AND INVESTIGATE THE COMPLAINT BUT USER DID NOT RESPOND OR RETURN THE KARDIAMOBILE 6L DEVICE FOR HARDWARE INVESTIGATION. ALIVECOR'S KARDIAMOBILE 6L DEVICE IS A LEAD-I AND LEAD-II MOBILE EKG DEVICE THAT IS NOT INTENDED TO DETECT LONG QT SYNDROME (LQTS). IT APPEARS THAT THE DEVICE LIKELY HAD NO MALFUNCTION, DID NOT CAUSE OR CONTRIBUTE TO THE CARDIAC ARREST, AND THE INCIDENT WAS A RESULT OF USER ERROR.

    Description of Event or Problem · 1

    USER'S HUSBAND CONTACTED ALIVECOR ON SEPT. 22, 2020 WITH A COMPLAINT REGARDING HER KARDIAMOBILE 6L DEVICE. USER WAS REPORTED TO BE USING HER KARDIAMOBILE 6L AND READINGS "SHOW UP AS NORMAL". ON (B)(6) 2020, USER SUFFERED CARDIAC ARREST AND SURVIVED. SUBSEQUENTLY, USER'S HUSBAND STATED THAT THE USER HAS "LONG QT WHICH WAS THE PRECURSOR" TO THE CARDIAC ARREST. USER'S SPOUSE EXPRESSED CONFUSION THAT THE DEVICE ALGORITHM DID NOT DETECT THE LONG QT AND MAY HAVE DELAYED SEEKING MEDICAL TREATMENT DUE TO THE KARDIAMOBILE 6L RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159920 KARDIAMOBILE 6L MOBILE ELECTROCARDIOGRAM DXH ALIVECOR, INC. AC-019

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening