BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADU

    MDR report key: 897128 · Received August 15, 2007

    Report

    Report Number
    9610105-2007-00028
    Event Type
    Other
    Date Received
    August 15, 2007
    Date of Event
    July 19, 2007
    Report Date
    August 15, 2007
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    K050676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: WHEN THE FRESH GAS TUBE OF THE ADU IS MISCONNECTED TO THE VENTILATION HOSE OF THE BELLOWS BLOCK, AS IN THE REPORTED COMPLAINT, THE FRESH GAS FLOW WILL FLOW TO THE BELLOWS BLOCK INSTEAD OF THE PT. THERE IS ONLY SLIGHT MOVEMENT OF THE BELLOWS AND PROPER AUTO/MECHANICAL VENTILATION IS NOT POSSIBLE. IN THIS SITUATION, THE ADU IS DESIGNED TO ALARM WHEN VENTILATION IS STARTED IN THE AUTO MODE (RED ALARM WILL BE "PEAK HIGH" WITH THE WHITE NOTE" PMAX RELEASE"). ADDITIONALLY, AFTER APPROX 5 TO 10 BREATHING CYCLES, "CANNOT DELIVER SET VOL" YELLOW ALARM MESSAGE WILL BE DISPLAYED ON THE ADU SCREEN. THE MISCONNECTION AS DESCRIBED WILL PASS THE AUTOMATIC PART OF THE ADU SYSTEM CHECK. HOWEVER, THE STATUS CHECKS WOULD FAIL AS THERE IS NO FRESH GAS FLOW THOUGH THE COMPACT BLOCK. THE USER'S REFERENCE MANUAL HAS BEEN REVIEWED AND FOUND TO BE ADEQUATE. THERE ARE DETAILED INSTRUCTIONS HOW TO PROPERLY CONNECT ALL TUBES AND THE PT CIRCUIT. THERE ARE ALSO INSTRUCTIONS FOR PERFORMING THE STEP-BY-STEP DAILY SYS CHECK OF THE ADU. A PROPERLY COMPLETED PREOPERATIVE CHECK OF THE EQUIPMENT IS DESIGNED TO PICK UP SUCH A CONDITION. ADD'L IN-SERVICE TRAINING HAS SUBSEQUENTLY BEEN PROVIDED TO THE CUSTOMER IN AN EFFORT TO HELP PREVENT A RECURRENCE OF THE REPORTED COMPLAINT. PROPER SERVICE PROCEDURES HAVE BEEN REVIEWED WITH THE GE HEALTHCARE SERVICE REP.

    Description of Event or Problem · 1

    A PLANNED MAINTENANCE (PM) HAD BEEN PERFORMED ON THE MACHINE BY A GE HEALTHCARE SERVICE REP TWO DAYS PRIOR TO THE ALLEGED EVENT. AT THE COMPLETION OF THE PM, THE SERVICE REP INADVERTENTLY LEFT THE VENT HOSE CONNECTED TO THE FGC OUTPUT, WHICH WAS USED DURING THE TESTING PROCESS. THE ALLEGED CASE WAS THE FIRST CASE AFTER THE PM. THE CUSTOMER REPORTEDLY DID NOT NOTE THE IMPROPER HOSE CONNECTION. PRIOR TO THE START OF THIS CASE, THE PORTION OF THE CHECKOUT BUT DID NOT PERFORM THE STATUS CHECKS. THE PT WAS INTUBATED AND PARALYZED. THE CUSTOMER REPORTEDLY NOTED THE MACHINE ALARMED 'HIGH PRESSURE'. THE PROPER PLACEMENT OF THE ENDOTUBE WAS VERIFIED. THE CLINICIAN REPORTEDLY THOUGHT THE PT'S BRONCHIAL TUBES WERE BLOCKED, AND MEDICATION WAS GIVEN TO THE PT. THE ALARM WAS REPORTEDLY STILL SOUNDING. THE PT WAS REPORTEDLY SWITCHED TO AN AMBU BAG WHICH RESOLVED THE REPORTED COMPLAINT. THE PT WAS REPORTEDLY SWITCHED BACK TO MECHANICAL VENTILATION AND THE ALARM SOUNDED AGAIN. THE PT REPORTEDLY WENT INTO ASYSTOLE AND WAS MOVED TO ANOTHER ROOM. THE PT WAS REPORTEDLY RESUSCITATED AND HAS BEEN RELEASED FROM THE HOSPITAL WITH NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU ANESTHESIA MACHINE BSZ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR