BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881155 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03027
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT YET BEEN RETURNED TO ZOLL FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT AND COMPLETION OF THE EVAL OF THE MONITOR AND ELECTRODE BELT. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE REPORTEDLY DEFECTIVE MONITOR AND BELT. THE PT RECEIVED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF AN (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S DEVICE WAS DISPLAYING A SERVICE CODE 107 (ABNORMAL SHUTDOWN) AND A SERVICE CODE 102 (CHARGE PROFILE FAULT). THE PT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR