BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL LIFEVEST K0606 AED GARMENT W/ELECT ANALYSIS

    MDR report key: 4080843 · Received September 4, 2014

    Report

    Report Number
    MW5038132
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    October 1, 2013
    Manufacturer
    ZOLL
    Product Code
    MVK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY LIFE VEST ISSUED A WARNING THAT, IT WAS ABOUT TO ZAP ME. MY HUSBAND SAID TAKE THE VEST OFF QUICK SO I DID. WE CALLED MY DR. (B)(6) AND HE SAID GO TO URGENT CARE. WHEN WE ARRIVED NO ONE IN THE ENTIRE ER KNEW WHAT THE HECK A LIFE VEST WAS. SO MY HUSBAND CALLED ZOLL AND INFORMED THE ER STAFF ON HOW TO USE IT. THEY SENT ME ANOTHER LIFE VEST SAYING OBVIOUSLY IT WAS TOO BIG. IT CONSTANTLY SENT MESSAGE INFORMING ME I WAS TO BE "ZAPPED". CALLER WAS TOLD VEST WAS TOO BIG - VEST TOO SMALL - VEST DIRTY - VEST TOO CLEAN ETC. RECEIVED 12 LIFEVESTS; ALWAYS RECEIVED THE SAME WARNING. FINALLY WE WERE IN THE AUDIENCE WATCHING OTHELLO AND GOT THE WARNING DO NOT STAND NEAR THIS PERSON MESSAGE. SO I TURNED IT OFF AND PACKED IT UP AND SENT IT BACK. GOOD RIDDANCE. THEY NEED TO CLEAR THE ARTIFACTS UP AND ALSO INFORM MEDICAL STAFF ABOUT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539537 ZOLL LIFEVEST K0606 AED GARMENT W/ELECT ANALYSIS LIFEVEST MVK ZOLL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other CARVEDIOL,| POTASSIUM,| DYAZIDE| ST JUDE MERLIN PACEMAKER,| VICTOZA,| AVAPRO,