BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1900096 · Received November 12, 2010

    Report

    Report Number
    3002158293-2010-01188
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL THE CONNECTOR ON THE TRUNK CABLE WAS MISSING. THE ROOT CAUSE OF THE MISSING CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY PROBLEMS WITH IT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, ELECTRODE BELT SN (B)(4) HAD A MISSING CONNECTOR ON THE TRUNK CABLE. THE 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 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA