BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 1631008 · Received March 9, 2010

    Report

    Report Number
    2510954-2010-00003
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 6, 2010
    Report Date
    February 8, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    BSZ
    PMA / PMN Number
    K963994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A DRAEGER SERVICE TECHNICIAN. THE DEVICE PERFORMED TO SPECIFICATION AND PASSED ALL VENTILATOR TESTS. NO DEVICE FAILURES WERE NOTED. ALTHOUGH WITHIN SPECIFICATIONS, THE INSPIRATORY FLOW REGULATOR WAS FOUND TO BE OPERATING CLOSE TO THE TOLERANCE LIMIT. THIS WOULD NOT HAVE AFFECTED MANUAL VENTILATION AS THE INSPIRATORY FLOW REGULATOR ONLY UTILIZED DURING MECHANICAL VENTILATION. IT WAS REPORTED BY THE INITIAL REPORTER THAT THERE WERE NO PROBLEMS VENTILATING THE PT IN MECHANICAL VENTILATION MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DOCTOR WAS HAVING DIFFICULTY VENTILATING THE PT IN MANUAL VENTILATION MODE. THE PEAK BREATHING PRESSURE STARTED INCREASING AND WOULD NOT DECREASE. THE DOCTOR ALSO TRIED VENTILATING WITH AN AMBU BAG BUT WAS STILL HAVING DIFFICULTY. THE DOCTOR INSERTED A CHEST TUBE AND IT WAS REPORTED THAT VENTILATION BECAME EASIER. THE CASE WAS COMPLETED. THERE WERE NO PROBLEMS NOTED WHEN THE PT WAS VENTILATED USING MECHANICAL VENTILATION ON THE ANESTHESIA MACHINE. IT WAS REPORTED THAT 2 DAYS AFTER THE CASE, THE PT HAD NOT REGAINED CONSCIOUSNESS AND THE PT APPEARS TO BE NEUROLOGICALLY COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAGER MEDICAL SYSTEMS, INC. (PNC) GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other