BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3172754 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01503
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RETURNED TO ZOLL. THE PATIENT'S NURSE REPORTED A DAMAGED CABLE AND EXPOSED WIRES AS WELL AS ALARMS FROM THE MONITOR INDICATING A CONNECTION ISSUE WITH THE ELECTRODE BELT. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE ROOT CAUSE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE ALLEGED DAMAGED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A PULLED CABLE AND EXPOSED WIRES ON THE ELECTRODE BELT AS WELL AS ALARMS FROM THE MONITOR INDICATING A CONNECTION ISSUE WITH THE ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241717 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR