BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1920938 · Received December 7, 2010

    Report

    Report Number
    3002158293-2010-01293
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 3, 2010
    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 EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 102) WAS CONFIRMED. UPON EVAL, CHARGE PROFILE FAULTS WERE SEEN, CAUSING THE SVC CODE 102. THE COMPUTER/ANALOG BOARD ON THE MONITOR HAD A DEFECTIVE SWITCHING REGULATOR COMPONENT, U1. THE ROOT CAUSE OF THE DEFECTIVE U1 CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY DUE TO A RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6), MALE, PT'S SON, CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE HAD AN ALARM TO CALL FOR SVC AND CODE 102 ON HIS MONITOR. SUPPORT ISSUED THE PT A REPLACEMENT MONITOR.

    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 68 YR