BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3636720 · Received December 18, 2013

    Report

    Report Number
    3008642652-2013-03545
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 9, 2013
    Report Date
    December 17, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 PROBLEMS (GEL PREVIOUSLY RELEASED FLAGS AND DAMAGED CABLE) WERE CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF AND THE WIRES WERE DETACHED FROM THE DISTRIBUTION NODE PCB. THE DETACHED WIRES CAUSED THE REPORTED MESSAGES. THE ROOT CAUSE OF THE PULLED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    UPON REVIEW OF A (B)(6) MALE PT'S FLAG FILES, ZOLL CUSTOMER SUPPORT REPORTED "GEL PREVIOUSLY RELEASED" FLAGS WITHOUT A "GEL RELEASED" FLG. WHEN THE PT WAS CONTACTED HE REPORTED EXPOSED WIRES THE DISTRIBUTION NODE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663819 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR