BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANESTHESIA SYSTEM

    MDR report key: 1744543 · Received June 25, 2010

    Report

    Report Number
    3023361-2010-00018
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 23, 2010
    Manufacturer
    SPACELABS HEALTHCARE LTD
    Product Code
    BSZ
    PMA / PMN Number
    K051629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS INVESTIGATING THE REPORTED FAILURE OF THE BACKBAR VALVES RETURNED BY THE CUSTOMER. AT THIS TIME, WE ARE ATTEMPTING TO REPRODUCE THE REPORTED SYMPTOMS AND IDENTIFY THE ROOT CAUSE. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A DOCTOR IN A (B)(6) REPORTED THAT DURING AN OPERATION, A BLEASESIRIUS ANESTHESIA MACHINE BACKBAR VALVE DID NOT OPEN CORRECTLY AND ANESTHETIC GAS WAS NOT DELIVERED CORRECTLY TO PATIENT. THE DOCTOR CONFIRMED THAT THERE WAS NO PATIENT INJURY.

    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 Other