BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOME KARDIA

    MDR report key: 8605199 · Received May 13, 2019

    Report

    Report Number
    3010112812-2019-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    December 4, 2018
    Report Date
    December 5, 2018
    Manufacturer
    INFOBIONIC INC.
    Product Code
    DSI
    PMA / PMN Number
    K160064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY PACK WAS RECEIVED BACK FROM THE PATIENT WITH MECHANICAL DAMAGE. THE COVER OF BATTERY PACK, WITH LOT CODE INFORMATION, WAS MISSING. INVESTIGATION REVEALED EXTENSIVE WATER DAMAGE TO THE BATTERY PCM (PROTECTIVE CIRCUIT MODULE). THE WATER ACTED AS AN ELECTRICAL CURRENT CONDUCTOR ALLOWING THE CURRENT FROM THE BATTERY TO BYPASS THE PROTECTION CIRCUITRY AND THE ENERGY STORED IN THE BATTERY WAS RELEASED MOMENTARILY. IT WAS CONCLUDED THAT THE BATTERY PACK WAS SUBJECTED TO AN IMPACT, SUFFICIENT TO BREAK THE ULTRASONIC WELD AND DETACH THE BATTERY COVER. THE DAMAGED BATTERY PACK WAS SUBSEQUENTLY PLACED ON A SURFACE WITH ENOUGH WATER PRESENT TO SEEP ACROSS BOTH SIDES OF THE PCM. THIS CAUSED SEVERAL COMPONENTS ON THE PCM PWA TO SHORT AND OVERHEAT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED ON STANDALONE LI-ION BATTERY PACK WHICH IS COMPONENT OF INFOBIONIC MOME KARDIA DEVICE. THE MEDICAL PRACTICE STAFF REPORTED THAT THE PATIENT RETURNED THE DEVICE WITH BATTERY PACK WITH FRONT (FRONT COVER OF BATTERY PACK) OFF IT. THE INSIDE OF THE BATTERY PACK WAS EXPOSED. THE AREA WITH THE 6 GOLD BARS WAS CHARRED AS WELL AS CHARRING ON THE SILVER COLORED PLATE. THE PATIENT'S HUSBAND STATED THAT HE HAD JUST REMOVED THE BATTERY FROM THE MONITOR IN ORDER TO PLACE A FRESH BATTERY. HE PLACED THE USED BATTERY ON THE COUNTER AND HE OBSERVED IT "SMOKING". HE STATED THAT THE BATTERY HAD BEEN USED WITHOUT INCIDENT UP TO THIS POINT. SINGLE BATTERY PACK WAS INVOLVED WITH SINGLE PATIENT. NO PATIENT INJURY OR ANY OTHER DAMAGE WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398602 MOME KARDIA AMBULATORY ECG MONITORING AND DETECTION SYSTEM DSI INFOBIONIC INC. 01854

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other