BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173279 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01530
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    December 22, 2012
    Report Date
    June 6, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE OR WIRES EXPOSED) WAS CONFIRMED. UPON RECEIPT, THE TRUNK CABLE CONNECTOR WAS DETACHED FROM THE TRUNK CABLE RENDERING THE BELT UNABLE TO CONNECT TO THE MONITOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT AN UNKNOWN PATIENT'S ELECTRODE BELT HAD A DAMAGED CABLE. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254005 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK