BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221500 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01734
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOWNLOAD CODE 139) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE MONITOR REVEALED A DOWNLOAD CODE 129. THIS SERVICE CODE IS INDICATIVE OF A SEGMENTATION FAULT DURING A DATA DOWNLOAD. THE CAUSE OF THE SEGMENTATION FAULT IS A FLASH MEMORY FAILURE. THE CAUSE OF THE FLASH MEMORY FAILURE HAS BEEN ISOLATED TO FLASH COMPONENTS ON THE COMPUTER ANALOG (CA) BOARD SN (B)(4). THE FLASH MEMORY COMPONENTS HAD INTERMITTENT BGA CONNECTIONS. 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. ROT 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 ON (B)(4) 2013. RESULTS WILL BE MONITORED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS HAVING DIFFICULTY DOWNLOADING HIS MONITOR. A PT SERVICE REPRESENTATIVE WAS DISPATCHED AND NOTIFIED ZOLL CUSTOMER SUPPORT THAT A SERVICE CODE WAS DISPLAYED ON THE PT'S MONITOR. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300674 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR