BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3210030 · Received June 27, 2013

    Report

    Report Number
    3008642652-2013-01707
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED TVA4 TVS ARRAY ON THE AUXILIARY PCA BOARD. THE ROOT CAUSE FOR THE SHORTED TVA4 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED TVA4 COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293674 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR