BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4261826 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-04023
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    April 25, 2014
    Report Date
    November 12, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ELECTRODE BELT SN (B)(4) WAS NOT RETURNED FOR THE EVENT INVESTIGATION. BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. ON (B)(6) 2014 THE SON OF A (B)(6) YEAR OLD FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT HAD SORES UNDER HER BREAST FROM THE LIFEVEST. WHILE FOLLOWING UP WITH THE PT, A ZOLL PT SERVICE REP (PSR) REPORTED THAT THE PT'S SKIN WAS RAW AND BLEEDING UNDER THE FRONT THERAPY ELECTRODE (TE). THE PT WAS USING AN OIL BASED CREAM AND ZINC OXIDE POWDER ON THE IRRITATION. THE PT CONTINUED TO WEAR THE LIFEVEST. IT IS UNK WHETHER THE PT REQUIRED MED INTERVENTION. THE CLINICAL OUTCOME OF THE SORES IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735871 LIFEVEST WCD 3100 SYSTEM MVK ZOLL MANUFACTURING CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR