BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3192367 · Received June 18, 2013

    Report

    Report Number
    3008642652-2013-01599
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 20, 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. UPON EVAL, THE TRUNK CABLE WAS PULLED WHICH DAMAGED THE J702 CONNECTOR (TRUNK CABLE CONNECTOR) INSIDE THE DISTRIBUTION (DN). THE CAUSE OF THE TEST FAILURES WAS THE DAMAGED J702 CONNECTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE PLACED ON THE TRUNK CABLE. THE SOURCE OF THE EXCESSIVE FORCE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLES. THE LAST PT TO USE THIS E-BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING E-BELT SN (B)(4), THE E-BELT FAILED THE HI-POT AND FALL-OFF TESTS. THE LAST PT TO USE THIS E-BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277444 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA