BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881157 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03043
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 15, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVAL, THE MONITOR WOULD NOT POWER ON. UPON INVESTIGATION, THERE WAS A SEGMENTATION FAULT WHILE PERFORMING THE FLASH MEMORY TEST. THE CAUSE OF THE PROBLEM WAS ISOLATED TO FLASH MEMORY COMPONENTS U1-2 AND U105 ON COMPUTER ANALOG (CA) BOARD SN (B)(4). A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER UP. THE PT 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 32 YR