BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3191013 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01560
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE WAS PULLED FROM THE STRAIN RELIEF, DAMAGING CONNECTOR J702 ON THE DISTRIBUTION NOT PCA BOARD. THE DAMAGE INTERRUPTED MONITOR/BELT COMMUNICATION AND CAUSED THE SERVICE CODE 204. THE ROOT CAUSE FOR THE STRAINED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE STRAINED CABLE. THE PT REC'D A REPLACEMENT ELECTRODE BELT. DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. AS REC'D, 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 INDUCE 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 THE SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. A MECHANICAL DESIGN CHANGE TO REDUCE TO 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 COMPONENTS. THE PT REC'D A REPLACEMENT MONITOR. MANUFACTURE DATE: SN (B)(4): 03/2012.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REP CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS RECEIVING SERVICE CODES 204 AND 205. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT AND MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283438 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR