BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823814 · Received May 2, 2014

    Report

    Report Number
    3008642652-2014-01349
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CORROSION ON CONNECTOR J502 ON THE C/A BOARD, CAUSING THE +5V AND -5V POWER SUPPLIES AND CAPACITOR C19 TO SHORT. THE ROOT CAUSE FOR THE CORROSION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE CORROSION. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE MOTHER OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WAS NOT POWERING UP PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265260 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR