BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2890829 · Received November 20, 2012

    Report

    Report Number
    3008642652-2012-03060
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTON STUCK) HAS BEEN CONFIRMED. UPON RECEIPT THE FRONT RESPONSE BUTTON WAS STUCK INSIDE THE MONITOR. THE CAUSE FOR THE STUCK RESPONSE BUTTON WAS A CONTAMINATION INSIDE OF THE RESPONSE BUTTON. THE ROOT CAUSE FOR THE CONTAMINATION CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY INGRESS OF UNK SUBSTANCES DUE TO A MISSING RESPONSE BUTTON COVER. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RESPONSE BUTTON. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR'S RESPONSE BUTTONS WERE STUCK AND WOULD NOT ACTIVATE THE DEVICE. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR