BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821966 · Received September 28, 2012

    Report

    Report Number
    3008642652-2012-02552
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 25, 2012
    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 CUT, WHICH DAMAGED THE INTERNAL WIRES. THE ROOT CAUSE OF THE DAMAGED CABLE AND INTERNAL WIRES CANNOT BE POSITIVELY IDENTIFIED BY IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE WISE 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. THIS LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA