BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASE FOCUS ANESTHESIA SYSTEM

    MDR report key: 2920761 · Received January 17, 2013

    Report

    Report Number
    3023361-2013-00011
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    BSZ
    PMA / PMN Number
    K003251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER ON SITE EVALUATED THE SYSTEMS, AND DETERMINED THAT THE ABSORBER USED ON THE SYSTEMS IS DEFECTIVE AND MUST BE REPLACED. SPACELABS WILL IMPLEMENT A RECALL OF THE AFFECTED SYSTEMS AND PERFORM A FIELD CORRECTIVE ACTION TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    SPACELABS ANESTHESIA SYSTEMS RECENTLY PURCHASED BY (B)(4) ARE SHOWING HIGH INSPIRATORY CO2 LEVELS WHEN BEING USED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26775 BLEASE FOCUS ANESTHESIA SYSTEM ANESTHESIA GAS-MACHINE BSZ SPACELABS MEDICAL INC. FOCUS

    Patients

    Seq Age Sex Outcome Treatment
    1