BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221493 · Received July 3, 2013

    Report

    Report Number
    3008642652-2013-01741
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 (ABNORMAL SHUTDOWNS) WAS CONFIRMED. UPON INVESTIGATION, THE MONITOR WAS RESETTING. THE CAUSE FOR THE RESETS ARE ISOLATED TO AN INTERMITTENT BGA SOLDER CONNECTION AT THE U500 DSP COMPONENT ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE INTERMITTENT BGA CONNECTION AT U500 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 ((B)(4)) TO REDUCE THE PCA STRAIN WAS APPROVED BY FDA ON (B)(4) 2012. IMPLEMENTATION BEGAN (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U500 COMPONENT. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS DISPLAYING A SERVICE CODE 107 (ABNORMAL SHUTDOWNS). THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304648 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR