BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221397 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00460
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 203) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER UP BEYOND THE SERVICE CODE 203 SCREEN. UPON EVAL, IT WAS DISCOVERED THAT THE OUTPUT SIGNAL FROM COMPONENT U903 (UNITY GAIN OP AMP BUFFER) ON THE COMPUTER/ANALOG (CA) BOARD WAS VERY NOISY. A MUX (MULTIPLEXING DEVICE) TAKES SAMPLES FROM VARIOUS SIGNALS ON THE CA BOARD. THE MUX ALLOWS FOR MULTIPLE SIGNALS TO BE SENT AT ONE TIME IN A SINGLE SIGNAL. COMPONENT U903 CONVERTS THE CURRENT OUTPUT FROM THE MUX TO A VOLTAGE OUTPUT. U903 PROTECTS THE MUX SIGNAL BY CREATING A HIGH IMPEDANCE SIGNAL. THE ROOT CAUSE FOR THE U903 NOISY OUTPUT SIGNAL CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR RETURNED A MONITOR FOR A CODE 203.

    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 NA