BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3925403 · Received July 3, 2014

    Report

    Report Number
    3008642652-2014-02044
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S MONITOR (SN (B)(4)) AND ELECTRODE BELT (SN (B)(4)) WERE RETURNED TO ZOLL AND FOUND TO BE FULLY FUNCTIONAL. THERE WAS NO DEVICE FAILURE.

    Description of Event or Problem · 1

    THE NURSE OF AN (B)(6) YEAR OLD MALE PT, CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT HAD SOME SKIN ABRASIONS BENEATH THE ELECTRODE BELT ELECTRODES. ZOLL CUSTOMER SUPPORT SUGGESTED THAT THE PT'S GARMENTS SHOULD BE CHANGED EVERY DAY AND THAT THE PT'S PHYSICIAN SHOULD BE CONSULTED IF ANY MEDICATION IS REQUIRED. THE PT'S DAUGHTER IN-LAW CONTACTED ZOLL CUSTOMER SUPPORT ON (B)(6) 2014 TO REPORT THAT, DUE TO THE SEVERITY OF THE SKIN BREAKDOWN, THE PT HAD REMOVED THE DEVICE. AFTER CONTACTING THE PT'S CARDIOLOGIST, THE PT ENDED USE. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389125 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIB MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention