BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3192343 · Received June 18, 2013

    Report

    Report Number
    3008642652-2013-01603
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 12, 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 REC'D, THE ELECTRODE BELT FAILED THE PULSE LEAD HI-POT AND FUNCTION-FALL OFF TESTS. THE CAUSE WAS A DEFECTIVE U723, A LOW CAPACITANCE, LOW CHARGE INJECTION MULTIPLEXER, ON THE DISTRIBUTION NODE (DN) PCA. PINS 10 AND 12 WERE OUT OF TOLERANCE. 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 PULSE LEAD HI-POT AND FUNCTIONAL 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
    276061 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA