BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRUS

    MDR report key: 3123863 · Received March 4, 2013

    Report

    Report Number
    3123863
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 3, 2013
    Manufacturer
    SPACELABS MEDICAL, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    A BREATH COULD NOT BE DELIVERED IN BAG MODE DURING INDUCTION.======================MANUFACTURER RESPONSE FOR ABSORBER ON ANESTHESIA MACHINE, BLEASESIRUS (PER SITE REPORTER).======================MANUFACTURER HAS ACKNOWLEDGED THEY HAVE BEEN ABLE TO REPRODUCE THE INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92779 BLEASESIRUS VENTILATOR, CONTINUOUS, FACILITY USE CBK SPACELABS MEDICAL, INC 12200902 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *