BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIVECOR KARDIABAND

    MDR report key: 7533649 · Received May 21, 2018

    Report

    Report Number
    MW5077351
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    ALIVECOR, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UPON CALLING CUSTOMER SERVICE AT ALIVCOR BECAUSE THEIR KARDIA WATCH WAS NOT WORKING (IT WOULD NOT RECORD MY EKG), I WAS ASKED IF I HAD A HEARING AID OR A PACEMAKER. I HAVE A PACEMAKER PERMANENTLY IMPLANTED. I WAS THEN INFORMED THAT THE KARDIABAND WOULD NOT WORK WITH SUCH AN IMPLANTED DEVICE. I LOOKED ONLINE, FOUND THEIR INSTRUCTIONS FOR USE, AND IT WAS ONLY THEN THAT I READ THE WARNING THAT THE DEVICE SHOULD NOT BE USED IF YOU HAVE A PACEMAKER. THESE IFU'S ARE INADEQUATE, AS IT REQUIRES THE USER TO HAVE ACCESS TO THE ONLINE IFU'S. WARNINGS LIKE THESE SHOULD BE PRINTED AND FURNISHED WITH THE PRODUCT LABELING. THE COMPANY'S ONLINE ADVERTISING IS FALSE AND MISLEADING IN THAT NOWHERE DO THEY STATE IN THEIR COMPATIBILITY" CLAIMS THAT THE DEVICE CANNOT BE USED IN PTS WITH HEARING AIDS OR IMPLANTED DEVICES FOR CARDIAC RHYTHM, OR TO EVEN REFER TO THE INSTRUCTIONS FOR USE FOR ALL WARNINGS, PRECAUTIONS, INDICATIONS OR CONTRAINDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372856 ALIVECOR KARDIABAND ELECTROCARDIOGRAPH DPS ALIVECOR, INC. AC-011-42-A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR