BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1853461 · Received September 28, 2010

    Report

    Report Number
    3002158293-2010-00979
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 27, 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: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT HAD A CUT CABLE BETWEEN THE ECG C AND D. THE ROOT CAUSE FOR THE CUT CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT (B)(4), WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THERE WAS A CUT CABLE BETWEEN ECG C AND D. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY PROBLEMS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA