BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961442 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00166
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 15, 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 SERVICE EVAL, THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE CABLE WAS PULLED FROM THE DN. IN ADDITION, THE ECG C AND D CABLE WAS PULLED FROM THE GROMMET. THE CAUSE OF THE FAILED HIPOT TEST WAS THE PULLED CABLES. THE ROOT CAUSE OF THE PULLED CABLES WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE PULLED CABLES. 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 THE 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
    28404 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA