BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1942909 · Received December 23, 2010

    Report

    Report Number
    3002158293-2010-01353
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WON'T POWER UP) WAS CONFIRMED. UPON EVALUATION, THE MONITOR WOULD NOT POWER UP DUE TO DEBRIS ON THE EXPANSION PORT CONTACTS WHICH CAUSED A SHORT CIRCUIT ON THE LEADS. THE PROGRAMMABLE LOGIC DEVICE (PLD) WAS ALSO FOUND TO BE DAMAGED DUE TO THE DEBRIS, CAUSING AN INCORRECT OUTPUT VOLTAGE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A PSR ASSISTING A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WON'T POWER UP. THE PT RECEIVED 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 64 YR