BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANESTHESIA SYSTEM

    MDR report key: 1856538 · Received June 23, 2010

    Report

    Report Number
    3023361-2010-00016
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 21, 2010
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    BSZ
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS EVALUATED AT THE CUSTOMER'S LOCATION AND REPAIRED BY REPLACING THE TOUCHSCREEN ASSEMBLY. A REVIEW OF SIMILAR DEVICE EVALUATIONS, CONDUCTED AT SPACELABS, IDENTIFIED A CONDITION WHERE THE TOUCHSCREEN POWER CONNECTION COULD SHORT TO GROUND CAUSING THE VENTILATOR DISPLAY TO BLANK. WE HAVE CONCLUDED THAT IT IS POSSIBLE THAT OTHER BLEASESIRIUS DEVICES WITH SIMILAR TOUCHSCREEN ASSEMBLIES MAY FAIL IN A SIMILAR MANNER. SPACELABS HAS DECIDED TO IMPLEMENT A FIELD CORRECTION TO PREVENT OTHER CUSTOMERS FROM EXPERIENCING SIMILAR PROBLEMS. SPACELABS IS IN THE PROCESS OF NOTIFYING THE FDA'S (B)(4) DISTRICT OFFICE OF THIS ACTION.

    Description of Event or Problem · 1

    A POLISH HOSPITAL REPORTED THAT WHEN THE CLINICIAN TOUCHED THE BLEASESIRIUS MACHINE TOUCHSCREEN, THE DISPLAY ON THE VENTILATOR PORTION OF THE ANESTHESIA MACHINE WENT BLANK. THE VENTILATOR ITSELF CONTINUED TO FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1