BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221396 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00456
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) HAS BEEN CONFIRMED. THE CAUSE OF THE MONITOR NOT STARTING UP WAS A FLASH MEMORY FAILURE (COMPONENTS U102 AND U105) ON THE C/A BOARD. AN INTERMITTENT CONNECTION WAS DISCOVERED AT PIN A25 OF THE FLASH MEMORY. THE INTERMITTENT CONNECTION IS LIKELY DUE TO A FRACTURE 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 PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A LOUD HUMMING NOISE COMING FROM HIS MONITOR. WHEN CUSTOMER SUPPORT ASKED THE PT TO REMOVE AND RE-INSERT THE BATTERY, THE MONITOR WOULD NOT POWER ON. THE PT 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 CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR