BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2946260 · Received January 4, 2013

    Report

    Report Number
    3008642652-2013-00030
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    October 29, 2012
    Report Date
    January 3, 2013
    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 (WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION THERE WAS EXTENSIVE ELECTRICAL DAMAGE TO THE MONITOR C/A BOARD AND DEFIBRILLATOR BOARD. THE CAUSE FOR THE DAMAGE WAS HIGH CURRENT. THE CAUSE FOR THE HIGH CURRENT WAS A BROKEN LEAD ON A HIGH-VOLTAGE CAPACITOR C20 ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE BROKEN LEAD ON C20 COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR IMPACTING A HARD SURFACE. 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 FOR FDA REVIEW ON (B)(4) 2012 AND IS CURRENTLY UNDER REVIEW. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON C20. THE PT REC'D A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WOULDN'T POWER UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5903 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR