BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 17720399 · Received September 11, 2023

    Report

    Report Number
    3008642652-2023-08997
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 10, 2023
    Report Date
    September 11, 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

    COMPLAINANT ADDRESS AND TELEPHONE: ZOLL SERVICES, LLC 121 GAMMA DRIVE PITTSBURGH, PA 15238 (B)(6) USA. P027 (RASH OR SKIN IRRITATION OR BRUISING). P201 (MEDICAL INTERVENTION). A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION UNDER THE LIFEVEST EQUIPMENT. PATIENT DESCRIBED THE AREA AS ITCHY. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT¿S PHYSICIAN ADVISED TEMPORARILY REMOVING THE DEVICE FOR THE SKIN IRRITATION. FOLLOW UP INDICATED THAT THE SKIN IRRITATION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146817 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown