BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961393 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00148
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON EVALUATION, THE TRUNK CABLE WAS PULLED FROM THE STRAIN LIEF WHICH DAMAGED THE J702 CONNECTOR (TRUNK CABLE CONNECTOR) INSIDE THE DISTRIBUTION NODE. THE CAUSE FOR THE DAMAGED J702 CONNECTOR IS EXCESSIVE FORCE PLACED ON THE TRUNK CABLE. THE SOURCE OF THE EXCESSIVE FORCE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND CONNECTOR. THE LAST PATIENT TO USE THE ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) WAS FOUND TO HAVE A DAMAGED CABLE. THE LAST PATENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28250 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA