BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 400 SYSTEM

    MDR report key: 2241524 · Received August 10, 2011

    Report

    Report Number
    3008642652-2011-00406
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 8, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITORS (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION IT WAS FOUND THAT THE SD RAM (SYNCHRONOUS DYNAMIC RANDOM ACCESS MEMORY) CHIPS (COMPONENTS U100 AND U101) WERE CORRUPT AND NEEDED TO BE REPLACED IN BOTH MONITORS. A DEFECTIVE RAM WOULD PREVENT THE FLASH MEMORY FROM LOADING, THUS NOT POWERING UP THE MONITOR. THE ROOT CAUSE OF THE DEFECTIVE RAM CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT RAM. THE PATIENT RECEIVED A REPLACEMENT MONITOR. DEVICE MANUFACTURE DATE: MONITOR (B)(4): 04/2011; MONITOR (B)(4): 03/2011.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON. WHEN A PATIENT SERVICE REPRESENTATIVE (PSR) VISITED THE PATIENT TO REPLACE THE PATIENT'S MONITOR, THE PSR REPORTED THAT THE REPLACEMENT MONITOR WAS ALSO NOT POWERING UP. THE PATIENT WAS PROVIDED WITH A NEW REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 400 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR