BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANES CIRCUITS

    MDR report key: 1971735 · Received January 19, 2011

    Report

    Report Number
    2242551-2011-00001
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    November 12, 2010
    Report Date
    January 19, 2011
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PER UF REPORT #(B)(4): "A (B)(6) BOY UNDERWENT A SUCCESSFUL MINOR ORTHOPEDIC SURGERY AND WAS BROUGHT TO THE RECOVERY ROOM AT STILL INTUBATED BUT BREATHING ON HIS OWN. A BIFURCATED ANESTHESIA CIRCUIT USED WHILE THE PT IS ON THE VENTILATOR IN THE OPERATING ROOM WAS DETACHED FROM THE VENTILATOR AND USED AN OXYGEN DELIVERY SYSTEM FOR THE TRANSPORT TO THE RECOVERY ROOM. SUPPLEMENTAL OXYGEN WAS APPLIED IN TRANSIT FROM THE OPERATING ROOM TO RECOVERY. ONE END OF THE Y CIRCUIT WAS ATTACHED TO A PORTABLE O2 TANK, AND THE OTHER END LEFT OPEN AND LYING ON THE BOY'S CHEST. UPON ARRIVAL TO THE RECOVERY ROOM, THE PORTION OF THE TUBING ON THE CHEST WAS ATTACHED TO O2 ON THE WALL. SHORTLY AFTER ARRIVAL, THE CHILD'S CONDITION DETERIORATED AND IT WAS DISCOVERED THAT THE OXYGEN DELIVERY WAS BEING APPLIED TO BOTH ENDS CREATING A CLOSED CIRCUIT. NEITHER THE NURSE NOR THE ANESTHESIOLOGIST WAS AWARE THAT THE CHILD WAS GETTING O2 INTO BOTH SIDES OF THE CIRCUIT AND HAD NO OUTLET FOR EXPIRED AIR. THIS SITUATION CAUSED THE LUNGS TO FILL TO CAPACITY AND EVENTUALLY CAUSED DAMAGE TO THE LUNGS AND CARDIAC ARREST. DESPITE VIGOROUS ATTEMPTS TO RESUSCITATE THE CHILD BY MULTIPLE PEDIATRIC SPECIALISTS, THE EFFORTS WERE NOT SUCCESSFUL AND HE EXPIRED." GE HEALTHCARE HAS CONTACTED THE SITE REQUESTING ADDITIONAL INFORMATION. THERE IS NO ALLEGATION OF EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANES CIRCUITS ANESTHESIA CIRCUIT CAG VITAL SIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death