BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3150545 · Received May 29, 2013

    Report

    Report Number
    3008642652-2013-01401
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF E-BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204 - BELT/MONITOR UNUSABLE) WAS CONFIRMED. UPON INVESTIGATION THE E-BELT FAILED A HI-POT TEST. THE CAUSE WAS IMPROPERLY POSITIONED SHRINK TUBING ON THE PULSE WIRE'S SOLDER JOINTS. THE ROOT CAUSE FOR THE IMPROPERLY POSITIONED SHRINK TUBING WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204 (BELT/MONITOR UNUSABLE). THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234010 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR