BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2121428 · Received May 6, 2011

    Report

    Report Number
    3002158293-2011-00521
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 5, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST/CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVAL, PULSE WIRES WITHIN ECGS A AND B WERE NOT CONNECTED. THE CAUSE FOR THE DISCONNECTED PULSE WIRES CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF COLD SOLDERS. NO ADVERSE EVENT RESULTED FROM THE OPEN CONNECTION. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A PT SERVICE REP ASSISTING A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE IS RECEIVING CONSTANT CHECK THERAPY ELECTRODE PAD MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR