BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 16632609 · Received March 28, 2023

    Report

    Report Number
    3008642652-2023-03009
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 28, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A RASH UNDER THE FRONT THERAPY PADS OF THE LIFEVEST EQUIPMENT. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE RASH. THE PATIENT¿S PRE-HAB NURSE PROVIDED FENISTIL GEL FOR THE RASH. FOLLOW UP INDICATED THAT THE RASH IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650059 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown