BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3844866 · Received March 12, 2014

    Report

    Report Number
    3008642652-2014-00746
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PROBLEM (ADJUST BELT/CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN PULSE WIRE BETWEEN ECG "A" AND ECG "B". THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE CABLE SECTION. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING FREQUENT CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149298 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR