BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2983280 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00244
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 22, 2013
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK ELECTRODE BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVAL THE BROWN (LEAD 1-) WIRE WAS BROKEN NEAR THE HEX CRIMP FERRULE, CAUSING THE REPORTED ALARMS. THE ROOT CAUSE FOR THE BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE ELECTRODE BELT TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE BROKEN WIRE. THE PT ENDED USE AND THEREFORE DID NOT RECEIVE A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CONSTANT ADJUST BEL OR CHECK BELT MESSAGES. THE PT ENDED USE AND WAS THEREFORE, NOT PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47260 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR