BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890852 · Received November 20, 2012

    Report

    Report Number
    3008642652-2012-03082
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THERE WERE OPEN PULSE WIRES IN THE TRUNK CABLE CONNECTOR AND THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH THE MONITOR. THE CAUSE FOR THE INABILITY TO COMMUNICATE WITH THE MONITOR WAS THE OPEN PULSE WIRES IN THE TRUNK CABLE CONNECTOR. THE ROOT CAUSE FOR THE OPEN PULSE WIRES IN THE TRUNK CABLE CONNECTOR. THE ROOT CAUSE FOR THE OPEN PULSE WIRES CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE BROKEN PULSE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    UPON SERVICING OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR AN UNRELATED NONCONFORMANCE, THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE PATIENT 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 60 YR