BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1558774 · Received November 25, 2009

    Report

    Report Number
    3002158293-2009-00835
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    September 18, 2009
    Report Date
    November 23, 2009
    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: DEVICE EVAL OF ELECTRODE BELT (B) (4) HAS BEEN COMPLETED. UPON FURTHER INSPECTION, THE ELECTRODE BELT WAS FOUND TO HAVE A DEFECTIVE CABLE FROM ECG B TO THE DISTRIBUTION NODE. THE CABLE WAS RECONDITIONED AND THE ELECTRODE BELT WAS TESTED. BASELINE EVAL WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS DEFECT IS UNK, BUT APPEARED TO BE STRAIN PLACED ON THE CABLE BY PT WEAR. NO ADVERSE EVENT RESULTED FROM FAULTY ELECTRODE BELT. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT EXPERIENCE ANY PROBLEMS WITH IT.

    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 INTERMITTENT SHORT IN ONE OF THE CABLES. THE LAST PT TO USE THIS ELECTRODE 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA