BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 YSTEM

    MDR report key: 3033151 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00542
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 20, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (HIGH PITCHED SOUND/ REPEATED SHUT-DOWNS/ CODE 107) HAS BEEN CONFIRMED. UPON EVALUATION, THE MONITOR DISPLAYED CODE 107. THE CAUSE OF THE HIGH-PITCHED SOUND, REPEATED SHUTDOWNS, AND CODE 107 WAS AN INTERMITTENT CONNECTION AT BGA COMPONENT U500 (DSP) ON CA BOARD SN (B)(4). THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURED BGA 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. 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 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) FEMALE PT'S SPOUSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A HIGH-PITCHED SOUND COMING FROM THE MONITOR AND REPEATED SHUT-DOWNS. WHEN POWERED ON AGAIN, THE MONITOR ALSO DISPLAYED CODE 107 - MULTIPLE ABNORMAL SHUTDOWNS. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90195 LIFEVEST WCD 4000 YSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR