BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANAESTHESIA SYSTEM

    MDR report key: 2506521 · Received March 27, 2012

    Report

    Report Number
    3023361-2012-00011
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    March 5, 2012
    Report Date
    June 13, 2012
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    BSZ
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPACELABS ENGINEER EXAMINED THE CIRCUIT BOARD AND IDENTIFIED THE ROOT CAUSE OF THE SMOKE AND SMELL AS A BURNT VARISTOR ON THE ISOLATION TRANSFORMER ASSEMBLY. THE VARISTOR WAS OVERLOADED CAUSING THE MYLAR FILM ON THE CIRCUIT BOARD TO MELT RELEASING AN AMOUNT OF SMOKE. A REVIEW OF AVAILABLE DATA DID NOT IDENTIFY ANY SIMILAR COMPLAINTS. WE CONSIDER THIS FAILURE TO BE AN ISOLATED EVENT WITH NO FURTHER CORRECTIVE ACTION OR INVESTIGATION NEEDED. NO ONE HAS BEEN INJURED AS A RESULT OF THIS MALFUNCTION. A NEW TRANSFORMER ASSEMBLY WAS INSTALLED AND THE MACHINE PASSED ALL TESTS. THE CUSTOMER IS CONTINUING TO USE THE MACHINE. WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER INSPECTED THE SUBJECT DEVICE AT THE CUSTOMER'S SITE. THERE WAS NO VISIBLE DAMAGE ON THE OUTSIDE OF THE DEVICE. THE VENTILATOR WAS OPENED AND NO DAMAGE WAS FOUND. HOWEVER, THERE WAS A BURNT COMPONENT ON THE ISOLATION TRANSFORMER ASSEMBLY. THERE WERE NO OTHER DAMAGES NOTICEABLE TO OR AROUND THE TRANSFORMER. A NEW TRANSFORMER ASSEMBLY WAS INSTALLED IN THE MACHINE AND THE MACHINE PASSED ALL TESTS. THE CUSTOMER IS CONTINUING TO USE THE MACHINE. THE SUSPECT PARTS WERE RETURNED TO SPACELABS FOR INVESTIGATION. WE RECEIVED THE PARTS ON MARCH 21, 2012. THE INVESTIGATION IS STILL UNDERWAY. NO ONE HAS BEEN INJURED AS A RESULT OF THIS MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A SPACELABS ANESTHESIA MACHINE SMOKED AND EMITTED A SMELL OF ELECTRONICS BURNING.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A SPACELABS ANESTHESIA MACHINE SMOKED AND EMITTED A SMELL OF ELECTRONICS BURNING.

    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