BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3090053 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01107
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 18, 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. UPON INVESTIGATION, THE ELECTRODE BELT FAILED A PULSE LEAD HI-POT TEST. THE BLACK PULSE WIRE WAS OPEN IN THE TRUNK CABLE INSULATION. THE OPEN PULSE WIRE CAUSED THE TEST FAILURE. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE ON THE ELECTRODE BELT TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ELECTRODE BELT SN (B)(4) WAS RETURNED FOR AN UNRELATED NONCONFORMANCE. UPON RECEIPT, THE ELECTRODE BELT FAILED THE PULSE LEAD HI-POT TEST. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169476 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR