BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890848 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03067
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 27, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ZOLL LIFECOR CORP.
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 107) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR DISPLAYED CODE 107. THE CAUSE OF THE CODE 107 - MULTIPLE ABNORMAL SHUTDOWNS IS SRAM COMPONENT U1000 ON THE CA BOARD SN (B)(4). THE SRAM 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. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MEMORY. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A CODE 107. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR