BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2050104 · Received April 5, 2011

    Report

    Report Number
    3002158293-2011-00369
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 29, 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: EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ELECTRODE BELT WON'T CONNECT TO MONITOR) HAS BEEN CONFIRMED. THE ELECTRODE BELT CONNECTOR LOCKING NUT WAS MISSING. THE ROOT CAUSE FOR THE MISSING LOCKING NUT WAS NOT POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO EXCESSIVE FORCE. THE ELECTRODE BELT WAS OTHERWISE FULLY FUNCTIONAL AND COULD PROPERLY MONITOR A CARDIAC SIGNAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) ASSISTING A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS ELECTRODE BELT WOULD NOT SUCCESSFULLY CONNECT TO HIS MONITOR. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR