BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061768 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00847
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 26, 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. UPON EVAL, THE BLACK PULSE WIRE WAS DAMAGED INSIDE THE TRUNK CABLE. THE CAUSE FOR THE TEST FAILURE IS THE DAMAGED PULSE WIRE. THE ROOT CAUSE OF THE DAMAGED WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. 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 TE RECOGNITION TEST. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129584 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA