BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940410 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01187
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 16, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 (UNABLE TO BASELINE) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO OUT-OF-TOLERANCE PINS 9 AND 16 ON PROCESSOR U700 ON THE DISTRIBUTION NODE PCA. THE ROOT CAUSE FOR THE DEFECTIVE U700 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U700 COMPONENT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS UNABLE TO BASELINE A (B)(6) FEMALE PT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235613 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR