BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPREZZON

    MDR report key: 3426890 · Received October 2, 2013

    Report

    Report Number
    3426890
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    September 29, 2013
    Report Date
    October 2, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TWO EPISODES OF V-TACH. FIRST EPISODE OF V-TACH ALARMED APPROPRIATELY. THE SECOND EPISODE OF V-TACH, 8 BEATS) FAILED TO ALARM. THE MONITOR SHOULD HAVE SOUNDED AT THE BEDSIDE AND AT THE CENTRAL STATION, BUT DID NOT. THIS FACILITY HAS HAD THREE SIMILAR EVENTS IN THE LAST APPROXIMATE 2 WEEKS WITH THIS EQUIPMENT. NO PATIENTS WERE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497249 XPREZZON MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR MHX SPACELABS MEDICAL INC. XPREZZON *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR CARDIAC DRUGS