BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3090047 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01076
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 16, 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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE TRUNK CABLE WAS PULLED FROM THE DISTRIBUTION NODE (DN) STRAIN RELIEF, DAMAGING THE RED AND WHITE (PP+) WIRES INSIDE THE DN. THE ROOT CAUSE OF THE DAMAGED CABLE AND INTERNAL WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. 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 EVENT. DURING SERVICING, BELT SN (B)(4) WAS FOUND TO HAVE A DAMAGED CABLE. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169450 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA