BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080809 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00971
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 4, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE ELECTRODE BELT FAILED THE HI-POT TEST. UPON EVALUATION, THE PULSE WIRES INSIDE THE DISTRIBUTION NODE (DN) WERE SHORTED. THE CAUSE OF THE TEST FAILURE IS THE SHORTED WIRES. THE CAUSE OF THE SHORTED WIRES IS LOOSE SHRINK TUBING SURROUNDING THE WIRES. THE ROOT CAUSE OF THE LOOSE SHRINK TUBING CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED WIRES. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BELT SN (B)(4) FAILED THE HI-POT TEST. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159637 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA