BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2232978 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00247
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 11, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BELT CORD IS DAMAGED) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS FOUND THAT THE TRUNK CABLE WAS DAMAGED WITH SEVERED WIRES. THE ROOT CAUSE OF THE SEVERED WIRES CANNOT BE POSITIVELY IDENTIFIED, BUT AS RECEIVED, THE BELT APPEARED TO BE CHEWED APART BY AN ANIMAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE DEVICE WAS UNABLE TO POWER ON AND THAT THE ELECTRODE BELT CORD IS "MESSED UP." THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR