BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS

    MDR report key: 2495392 · Received March 14, 2012

    Report

    Report Number
    2495392
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 28, 2012
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WAS NOT ABLE TO VENTILATE THE PATIENT WITH THE SPACELABS BLEASE ANESTHESIA MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLEASESIRIUS GAS-MACHINE, ANESTHESIA BSZ SPACELABS HEALTHCARE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *