BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11798055 · Received May 10, 2021

    Report

    Report Number
    3008642652-2018-04312
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 16, 2018
    Report Date
    May 11, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE(TM) DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    5/10/2021- RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 5/11/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD SKIN IRRITATION DESCRIBED AS OZZING AND WEEPING SKIN. THE PATIENT CONSULTED HER PHYSICIAN WHO RECOMMENDED TO REMOVE THE LIFEVEST. FOLLOW-UP INDICATED THAT THE IRRITATION WAS GETTING BETTER AND HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692717 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention