BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2231395 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00305
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATED) WAS CONFIRMED. TREATMENT ANALYSIS SHOWS THAT THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS. THE PATIENT WAS CONSCIOUS AND BRUSHING HER TEETH AT THE TIME BUT DID NOT PRESS THE RESPONSE BUTTONS. UPON EVALUATION, THE DISTRIBUTION NODE PCA HAD INTERMITTENT FRONT END AND FALL-OFF FAILURES. THE ROOT CAUSE OF THESE FRONT END AND FALL-OFF FAILURES WAS A DEFECTIVE GAIN CONTROLLER. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE GAIN CONTROLLER. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS IN THE EMERGENCY ROOM AND THEY NEEDED THE DEVICE INTERROGATED. THE PATIENT HAD BEEN TREATED WHILE BRUSHING HER TEETH. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 62 YR