BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 2233357 · Received August 29, 2011

    Report

    Report Number
    2233357
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 29, 2011
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING PEDIATRIC HEART TRANSPLANT, VENTILATOR OF THE ANESTHESIA MACHINE MALFUNCTIONED. VENTILATOR FAILED TO TRIGGER THE BREATH HALFWAY THROUGH AN ANESTHETIC. SELF TEST OF THE ANESTHESIA MACHINE AND VENTILATOR TEST DID NOT RECOGNIZE ANY PROBLEMS PRIOR TO STARTING THE CASE. HAND VENTILATION WITH PRESSURIZATION OF CIRCUIT WAS POSSIBLE EXCLUDING CIRCUIT LEAK AS POSSIBLE CAUSE. AFTER HAND VENTILATING, REBOOTING, AND TESTING MACHINE, ABLE TO USE VENTILATOR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOLLO GAS-MACHINE, ANESTHESIA BSZ DRAEGER MEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA