BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3223916 · Received July 5, 2013

    Report

    Report Number
    3008642652-2013-01760
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 1, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE ELECTRODE BELT FAILED THE FUNCTIONAL-FALL OFF TEST. THE CAUSE WAS OUT OF TOLERANCE COMPONENT IN ECG D. V1, A TRANSIENT VOLTAGE SUPPRESSOR, WAS OUT OF TOLERANCE, PREVENTING THE ELECTRODE BELT FROM PASSING THE FALL-OFF TEST. THE ROOT CAUSE FOR THE OUT OF TOLERANCE COMPONENT WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE OUT OF TOLERANCE COMPONENT. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307094 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA