BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2885299 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03079
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED RESPONSE BUTTONS) WAS CONFIRMED. UPON INVESTIGATION, THE MONITOR'S RESPONSE BUTTON WERE NON-FUNCTIONAL. THE CAUSE OF THE NON-FUNCTIONAL RESPONSE BUTTONS WAS EXTENSIVE CONTAMINATION IN THE MONITOR. THE ROOT CAUSE FOR THE CONTAMINATION CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT OCCURRED DUE TO THE CONTAMINATED MONITOR. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE RESPONSE BUTTONS ON THE PT'S MONITOR WERE NOT FUNCTIONING PROPERLY. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    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 78 YR