BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3172806 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01474
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 30, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 100) WAS CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON PAST WRENCH CODE 100 - PROGRAM IMAGE CORRUPT. UPON EVAL, THE WHITE WIRE CONNECTING THE AUXILIARY BOARD TO THE COMPUTER/ANALOG BOARD WAS FOUND TO BE PHYSICALLY DAMAGED AND TO HAVE AN INTERMITTENT CONNECTION. THE CAUSE FOR THE INABILITY TO POWER ON PAST CODE 100 WAS ISOLATED TO CORRUPT MONITOR PROGRAMMING. THE CAUSE OF THE CORRUPT MONITOR PROGRAMMING WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO THE INTERMITTENT SIGNAL FROM THE DAMAGED WHITE WIRE. THE ROOT CAUSE FOR THE DAMAGED WHITE WIRE WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A CODE 100 (PROGRAM IMAGE CORRUPT). THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241398 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR