BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003649 · Received February 11, 2013

    Report

    Report Number
    3008642652-2013-00357
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 25, 2012
    Report Date
    February 6, 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 (SCREECHING/ DEFECTIVE) WAS CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON WAS A RAM FAILURE (COMPONENTS U100 AND U101) ON THE C/A BOARD SN (B)(4). THE RAM COMPONENTS HAD AN INTERMITTENT BGA CONNECTION. 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. ROOT CAUSE ANALYSIS OF SIMILAR EVENTS FOUND THAT EXCESSIVE STRAIN ON THE PRINTED CIRCUIT ASSEMBLY (PCA) FROM SEVERE IMPACT CAN CAUSE FRACTURED SOLDER CONNECTIONS. (B)(4). NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S SON CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE MONITOR WAS SCREECHING AND DEFECTIVE. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59253 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR