BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3812972 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01243
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (CHECK THERAPY PAD MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN WHITE PULSE WIRE IN THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO ECG "B." THERE WAS NO SIGN OF EXTERNAL DAMAGE TO THE CABLE. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251355 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR