BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2050190 · Received April 5, 2011

    Report

    Report Number
    3002158293-2011-00374
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 30, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE MONITOR WOULD NOT POWER ON. UPON EVAL, IT WAS DISCOVERED THAT THE L3 INDUCTOR ON THE DEFIBRILLATOR BOARD WAS OPEN. THIS WOULD NOT ALLOW THE 12V SUPPLY TO THE COMPUTER/ANALOG BOARD WHICH PREVENTED THE MONITOR FROM POWERING ON. THE ROOT CAUSE OF THE OPEN INDUCTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE INDUCTOR. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF MONITOR (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PRODUCT PROBLEM WAS DISCOVERED. THE MONITOR WAS UNABLE TO POWER ON. THE PT WAS PROVIDED WITH 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 55 YR