BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANAESTHESIA SYSTEM

    MDR report key: 2398115 · Received January 4, 2012

    Report

    Report Number
    3023361-2012-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 12, 2011
    Report Date
    April 13, 2012
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    BSZ
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS WORKING WITH A LOCAL SERVICE MANAGER TO CONDUCT TESTS AND COLLECT INFORMATION. INITIAL TESTING AT THE CUSTOMER'S SITE DUPLICATED THE REPORTED SYMPTOMS. AS TESTING CONTINUED THE DEVICE BEGAN TO OPERATE AND THE SYMPTOMS COULD NOT BE REPRODUCED. A REPLACEMENT ANAESTHESIA SYSTEM HAS BEEN SENT TO THE CUSTOMER SO THAT THE SUSPECTED PARTS CAN BE RETURNED TO SPACELABS FOR TESTING. SPACELABS IS WAITING TO RECEIVE THOSE PARTS TO START OUR INVESTIGATION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PARTS USED INLINE OF THE FRESH GAS FLOW PATH (FRESH GAS FLOW SENSOR, THE BACKBAR ASSEMBLY, AND THE COMMON GAS OUTLET (CGO) ASSEMBLY) WERE RETURNED TO SPACELABS FOR INVESTIGATION. THE PARTS WERE INSPECTED FOR ABNORMALITIES, DEBRIS, AND OCCLUSIONS. ALL PARTS WERE CLEAN AND INTACT. THESE PARTS WERE INSTALLED INTO A SIMILAR BLEASESIRIUS ANESTHESIA MACHINE, SERIAL NUMBER (B)(4), AND TESTED FOR OVER 10 HOURS. NO LEAK WAS DETECTED; ALL PARTS WORKED AS DESIGNED. WE ARE UNABLE TO REPRODUCE THE REPORTED FAILURE. THE RESULTS OF SPACELABS INVESTIGATION LEAD US TO CONCLUDE THAT THE BLEASESIRIUS ANESTHESIA MACHINE FUNCTIONED PER SPECIFICATION. THE CUSTOMER HAS BEEN ADVISED THAT THE SYMPTOMS REPORTED MAY BE OBSERVED IF THE VAPORIZER WAS NOT PROPERLY INSTALLED. IN FACT, THE CUSTOMER INCORRECTLY MOUNTED THE VAPORIZER AND NOTED THE SYMPTOMS IT HAD REPORTED. THE CUSTOMER HAS BEEN REFERRED TO THE PRODUCT OPERATIONS MANUAL, WHICH EXPLAINS CORRECT MOUNTING OF VAPORIZERS. ADDITIONALLY, SPACELABS PROVIDED A HANDS ON DEMONSTRATION TO THE CUSTOMER REGARDING PROPER MOUNTING OF VAPORIZERS. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A SPACELABS ANAESTHESIA MACHINE IN USE IN (B)(6) HAD NO FRESH GAS FLOW (OXYGEN, N2O, ANESTHETIC AGENT) DELIVERED TO THE BREATHING CIRCUIT ALTHOUGH THE FLOW METERS INDICATED THE FLOW WAS PRESENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A SPACELABS ANESTHESIA MACHINE IN USE IN (B)(6) HAD NO FRESH GAS FLOW (OXYGEN, N2O, ANESTHETIC AGENT) DELIVERED TO THE BREATHING CIRCUIT ALTHOUGH THE FLOW METERS INDICATED THE FLOW WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1