BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANESTHESIA SYSTEM

    MDR report key: 3959943 · Received June 20, 2014

    Report

    Report Number
    9611295-2013-00004
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    August 16, 2013
    Report Date
    August 23, 2013
    Manufacturer
    SPACELABS HEALTHCARE, LTD.
    Product Code
    BSZ
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS REPORTED EVENT. SPACELABS IS EVALUATING THIS REPORTED EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A BLEASESIRIUS ANESTHESIA SYSTEM FAILED TO VENTILATE A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363416 BLEASESIRIUS ANESTHESIA SYSTEM CBK: ANESTHESIA GAS-MACHINE BSZ SPACELABS HEALTHCARE, LTD. 14200100

    Patients

    Seq Age Sex Outcome Treatment
    1 12200902 ((B)(4))| 14200100 ((B)(4))