BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2843843 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02859
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 25, 2012
    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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CONNECTOR PINS) HAS BEEN CONFIRMED. UPON EVAL PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT. THE ROOT CAUSE FOR THE BENT PINS WAS UNABLE TO BE POSITIVELY IDENTIFIED, BUT WAS LIKELY EXCESSIVE FORCE APPLIED WHEN THE BELT WAS MATED WITH THE MONITOR. NO ADVERSE EVENT OCCURRED DUE TO THE BENT PINS IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REP CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT DURING A (B)(6) MALE'S PT FITTING THE PINS ON THE ELECTRODE BELT CONNECTOR WERE BENT. THE PT WAS PROVIDED WITH 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 WCB 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR