BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920525 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03232
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    September 25, 2012
    Report Date
    December 5, 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) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE MONITOR NOT POWERING ON WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD SN (B)(4). THE FLASH MEMORY HAD AN INTERMITTENT CONNECTION, WHICH WAS DISCOVERED THROUGH THE USE OF A FLASH MEMORY TEST. DURING THE FLASH MEMORY TEST THE MONITOR PRODUCED A SEGMENTATION FAULT. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED SOLDER CONNECTION INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTION MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE THE PCA STRAIN WAS SUBMITTED FROM FDA REVIEW ON (B)(4) 2012 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A PT'S MONITOR WAS NOT POWERING 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 NA