BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1162833 · Received September 9, 2008

    Report

    Report Number
    3002158293-2008-00434
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 8, 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 OF MONITOR HAD BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS A DEFECTIVE R46. R46 IS THE DISCHARGE RESISTOR. THE DEFIBRILLATOR BOARD WAS REPLACED. THE MONITOR WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE R46 IS UNKNOWN, BUT IS LIKELY RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR MADE A POPPING NOISE, GOT HOT, SMELLED LIKE SMOKE AND THEN SIZZLED. HE REMOVED THE BATTERY PACK. SUPPORT SENT THE PATIENT A REPLACEMENT 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 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR