BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1220822 · Received October 29, 2008

    Report

    Report Number
    3002158293-2008-00567
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. MONITOR WOULD NOT POWER UP BECAUSE THERE WAS WATER INSIDE THE MONITOR THAT LIKELY CAME IN FROM THE MODEM CONNECTOR. THE MODEM CONNECTOR WAS HEAVILY CORRODED. THE VOLTAGE ATTENUATOR (TVA3) WAS SHORTED ON THE AUXILIARY BOARD. THE ROOT CAUSE OF THE DEFECTIVE COMPONENTS LOOKED TO BE WATER DAMAGE. THE MONITOR WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT OCCURRED DUE TO THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE MONITOR GAVE A WRENCH CODE 6 "RESPONSE BUTTONS STUCK" THIS MORNING. SHE STATED THAT EVERY TIME THEY POWER UP THE MONITOR IT SAYS, "PLEASE RELEASE RESPONSE BUTTONS" BEFORE GIVING THE NORMAL" TO ACTIVATE DEVICE PLEASE PRESS RESPONSE BUTTONS". SUPPORT HAD THE PT ATTEMPT A DOWNLOAD. THE PT RESEATED THE BATTERY PACK AND THE MONITOR WOULD NOT POWER UP. NEITHER BATTERY PACK WOULD START THE MONITOR. SUPPORT SENT A PT SERVICES REPRESENTATIVE (PSR) TO THE PT TO REPLACE THE MONITOR.

    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 62 YR