BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1983690 · Received February 3, 2011

    Report

    Report Number
    3002158293-2011-00117
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    December 23, 2010
    Report Date
    February 1, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BELT WON'T STAY LATCHED TO MONITOR) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS BROKEN. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE PT IN REGARDING TO AN UNRELATED ISSUE WITH HIS BELT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT. UPON SERVICING OF BELT (B)(4), IT WAS FOUND THAT THE BELT WOULD NOT STAY SECURELY LATCHED TO THE MONITOR.

    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 68 YR