BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1884597 · Received October 25, 2010

    Report

    Report Number
    3002158293-2010-01088
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 20, 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 EVALUATION SUMMARY: EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE BATTERY CONNECTOR (J1) ON THE DEFIBRILLATOR BOARD WAS FOUND TO BE BROKEN, PREVENTING THE MONITOR FROM POWERING UP. THE ROOT CAUSE OF THE BROKEN BATTERY CONNECTOR CANNOT POSITIVELY BE DETERMINED BUT WAS LIKELY DUE TO EXCESSIVE FORCE WHEN THE BATTERY WAS MATED WITH THE MONITOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES. NO ADVERSE EVENT RESULTED FROM THE BROKEN BATTERY CONNECTOR.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR (B)(4) WAS FOUND TO HAVE A BROKEN BATTERY CONNECTOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA