BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843872 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02874
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 25, 2012
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. THE U1003 PROGRAMMABLE LOGIC DEVICE WAS SHORTED ON THE MONITOR C/A BOARD. THE CAUSE FOR THE SHORTED U1003 COMPONENT WAS ISOLATED TO DAMAGED HIGH-VOLTAGE CAPACITORS C20 AND C21 ON THE DEFIBRILLATOR BOARD. THE C20 AND C21 CAPACITORS HAD FRACTURED SOLDER JOINTS AND WERE DETACHED FROM THE DEFIBRILLATOR BOARD, WHICH LED TO A MISDIRECTED PULSE THAT SHORTED THE U1003 COMPONENT. THE ROOT CAUSE FOR THE DAMAGED C20 AND C21 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS NOT POWERING UP. THE PATIENT WAS ISSUED 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 30 YR