BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2885293 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03090
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A FALL-OFF TEST. THE CAUSE FOR THE TEST FAILURE AND THE REPORTED ALARMS WAS ISOLATED TO AN OPEN WHITE WIRE (DRIVEN GROUND) IN THE ELECTRODE BELT TRUNK CABLE. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN DRIVEN GROUND WIRE. THE PATIENT RECEIVED A REPLACEMENT BATTERY ELECTRODE BELT.

    Description of Event or Problem · 1

    (B)(6) MALE PATIENT'S NURSE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING ADJUST BELT OR CHECK BELT MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR