BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2212030 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00182
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 30, 2011
    Report Date
    July 8, 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 PROBLEMS (CONSTANT ALARMS; WATER DAMAGE) HAVE BEEN CONFIRMED. UPON EVALUATION CORROSION WAS DISCOVERED ON THE LCD, C/A, DEFIBRILLATOR AND AUXILIARY BOARDS. THE CAUSE FOR THE CORROSION WAS LIKELY LIQUID INGRESS WITHIN THE MONITOR. THE ROOT CAUSE FOR THE LIQUID INGRESS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE CORRODED BOARDS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER DEVICE WOULD NOT STOP ALARMING. SHE ALSO STATED SHE "CAN'T SEE THE SCREEN BECAUSE THERE [WAS] MOISTURE TRAPPED UNDER THE SCREEN." 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 61 YR