BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANAESTHESIA SYSTEM

    MDR report key: 4929883 · Received July 21, 2015

    Report

    Report Number
    3010157426-2015-00149
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 26, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE INSPECTION OF THE DEVICE BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE CUSTOMER STATED HIGH FLOWS WERE USED DURING THE PATIENT CASE TO COMPENSATE WHICH MAY HAVE INDICATED A LEAK IN THE PATIENT CIRCUIT. THE PATIENT CIRCUIT WAS DISCARDED BY THE CUSTOMER PRIOR TO THE ONSITE INSPECTION BY THE FSE. CONSEQUENTLY, THE PATIENT CIRCUIT COULD NOT BE INSPECTED. THE ANESTHESIA MACHINE PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO SERVICE BY THE CUSTOMER. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED. SPACELABS MONITORS ITS COMPLAINTS FOR SIMILAR PRODUCT ISSUES TO DETERMINE NEED FOR ADDITIONAL INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A SERVICE REPAIR REQUEST ON (B)(6) 2015 FOR BELLOWS COLLAPSE WHILE IN USE FOR A BLEASE SIRIUS ANESTHESIA SYSTEM. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473376 BLEASESIRIUS ANAESTHESIA SYSTEM ANAESTHESIA GAS-MACHINE CBK SPACELABS HEALTHCARE LTD. 14200100

    Patients

    Seq Age Sex Outcome Treatment
    1