BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5451166 · Received February 22, 2016

    Report

    Report Number
    3008642652-2016-00454
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    December 9, 2015
    Report Date
    January 27, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT/CHECK TE PAD MESSAGES/SERVICE CODE 204) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED THE TE RECOGNITION TEST. UPON INVESTIGATION THE SOLDER JOINT AT THE REAR PULSE WIRES IN THE DN WAS BROKEN. THE CAUSE OF THE FAILURE WAS A BROKEN SOLDER JOINT. THE ROOT CAUSE OF THE BROKEN SOLDER JOINT WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BELT SN (B)(4) INDICATING THAT A PATIENT WAS EXPERIENCING "ADJUST BELT" AND "CHECK BELT" MESSAGES AND WAS RECEIVING A SERVICE CODE 204 (BELT UNUSABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108816 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1