BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELAB HEALTHCARE BLEASESIRIUS ANESTHESIA VENTILATOR CART

    MDR report key: 15258188 · Received August 18, 2022

    Report

    Report Number
    MW5111581
    Event Type
    Injury
    Date Received
    August 18, 2022
    Report Date
    August 16, 2022
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GU, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO BACK TO BACK OPERATING ROOM OUTPATIENT PROCEDURES USING THE BLEASESIRIUS ANESTHETIC MACHINE VENTILATOR CART, SERIAL # (B)(4), MALFUNCTIONED RESULTING IN UNEXPECTED PNEUMOTHORAX OUTCOMES AND INCREASED LENGTH OF HOSPITAL STAY FOR BOTH PATIENTS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263625 SPACELAB HEALTHCARE BLEASESIRIUS ANESTHESIA VENTILATOR CART VENTILATOR, CONTINUOUS, FACILITY USE CBK SPACELABS HEALTHCARE INC. VENT MODEL 970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization