BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2882135 · Received November 12, 2012

    Report

    Report Number
    3008642652-2012-02962
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 5, 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT, THE ELECTRODE BELT FAILED A HIGH-POT TEST. INVESTIGATION REVEALED THE DN TO REAR TE CABLE WAS PULLED FROM STRAIN RELIEF. THE ROOT CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLES. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR NORMAL MAINTENANCE, THE DISTRIBUTION NODE (DN) TO REAR TE CABLE WAS PULLED FROM THE DN. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    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