BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2241562 · Received September 2, 2011

    Report

    Report Number
    3008642652-2011-00565
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 31, 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 (WILL NOT POWER ON) HAS BEEN CONFIRMED. UPON EVALUATION THE MONITOR WOULD NOT POWER UP. THE CAUSE OF THE FAILURE TO POWER UP WAS CORROSION ON CONNECTOR J5. THE ROOT CAUSE OF THE CORROSION ON THE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE CORRODED J5 COMPONENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE GRANDDAUGHTER OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER ON. 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 75 YR