BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221492 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01769
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 1, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (LOUD NOISE AND WOULD NOT POWER ON) WAS CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. DURING SERVICING, THERE WAS A "FAILED TO PROGRAM LOCATION" ERROR THAT REVEALED INTERMITTENT BGA CONNECTIONS ON RAM CHIPS U100 AND U101. ADDITIONALLY, THERE WAS A SEGMENTATION FAULTS THAT POINTED TO INTERMITTENT BGA CONNECTIONS AT FLASH COMPONENTS U102 AND U105. THE CAUSE FOR THE INABILITY TO POWER ON IS THE INTERMITTENT BGA CONNECTIONS ON THE COMPUTER ANALOG (CA) BOARD SN (B)(4). THE INTERMITTENT CONNECTIONS ARE LIKELY DUE TO A FRACTURED SOLDER CONNECTIONS INDUCED BY MECHANICAL STRESS. THE EXACT SOURCE OF THE MECHANICAL STRESS HAS NOT BEEN POSITIVELY IDENTIFIED BUT THE FRACTURED CONNECTIONS MAY HAVE BEEN ACCELERATED THROUGH ROUGH HANDLING. 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 WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT THAT HIS MONITOR MADE A LOUD NOISE AND THEN WOULD NOT POWER ON. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300502 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR