BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2140329 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00046
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM ("BATTERY IS NOT SHOWING ON THE BOX") HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY CONNECTOR (J1) PINS ON THE DEFIBRILLATOR BOARD WAS FOUND TO BE DAMAGED, PREVENTING THE MONITOR FROM POWERING UP. THE ROOT CAUSE OF THE DAMAGED BATTERY CONNECTOR PINS CANNOT POSITIVELY BE DETERMINED BUT WAS LIKELY DUE TO EXCESSIVE FORCE WHEN THE BATTERY WAS MATED WITH THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE BROKEN BATTERY CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT "BATTERY IS NOT SHOWING ON THE BOX." THE PATIENT WAS UNABLE TO GIVE ANY MORE DETAILS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR