BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3012687 · Received February 22, 2013

    Report

    Report Number
    3008642652-2013-00447
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 14, 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: DEVICE EVAL OF ELECTRODE BELT SN (B)(4), HAS BEEN COMPLETED. UPON EVAL, THE ELECTRODE BELT FAILED TO PULSE LEAD HIPOT TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE 16-BIT LOW POWER MICROCONTROLLER U713 ON THE DISTRIBUTION NODE PCA BOARD. PINS 38, 39, 42, 43, AND 55, WERE OUT OF TOLERANCE ON U713. THE ROOT CAUSE FOR THE U713 FAILURE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. 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 HIPOT 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
    78766 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA