BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3904896 · Received June 4, 2014

    Report

    Report Number
    3008642652-2014-01717
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 (WRENCH CODE 29) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. THE CAUSE FOR THE FAILURE WAS ISOLATED TO CORRUPTED AV FLASH MEMORY PROGRAMMING AND A BROKEN WHITE WIRE IN THE MONITOR. THE ROOT CAUSE FOR THE BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. THE MONITOR SHOWED SIGNS OF PHYSICAL ABUSE. THE ROOT CAUSE FOR THE FLASH MEMORY CORRUPTION COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM A (B)(6) MALE PATIENT REVEALED THAT THE PATIENT WAS RECEIVING A WRENCH CODE 29 (CHARGE PROFILE FAULT). ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND ISSUED HIM A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327988 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR