BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843892 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02819
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ZOLL LIFECOR CORP
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE ELECTRODE BELT FAILED THE THERAPY ELECTRODE RECOGNITION TEST AND THE PULSE LEAD HI-POT TEST. THE CAUSE FOR THE TEST FAILURES AND INABILITY TO TREAT WAS AN OPEN PULSE WIRE IN THE FRONT THERAPY ELECTRODE TO ECG-A CABLE. THE ROOT CAUSE FOR THE DAMAGED THERAPY ELECTRODES AND THE OPEN PULSE WIRE CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE LAST PT 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 BELT FAILED THE PULSE LEAD HI-POT TEST AND THE THERAPY ELECTRODE RECOGNITION TEST. THE LAST PT 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 CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA