Report of a Ventilation Mode Selector Switch Failure

Stuart Tilman, MD, Sem Lampotantg, PhD and Dietrich Gravenstein, MD
Department of Anesthesiology, University of Florida, Gainesville, Florida

The pre-use anesthesia apparatus checkout recommendation (AACR ) required by the FDA prior to administering anesthesia ascertains, among other elements, the integrity of the ventilator. We describe a case where the checkout detected a previously unknown and invisible failure mode of the ventilator in an Aestiva anesthesia machine (Datex-Ohmeda, Madison, WI).

We were alerted to a trauma patient’s arrival in our emergency department. Because the on- call staff had not used the anesthesia machine in the trauma room, the AACR was performed. The ventilator was checked by placing the Aestiva into ventilator mode with a fixed rate and volume and using the reservoir bag placed onto the Y-piece to simulate lungs, as described in step 12 of the AACR. It was noticed that the anesthesia machine’s ascending bellows were not returning fully to the initial volume and were continuing to lose volume with each ventilatory cycle despite a fresh gas flow of 5 L/min. The ventilation mode selector switch was flipped to the manual ventilation mode position and the machine examined. Despite a visual check of the circuit, the seating of the soda lime canisters and the hoses, no source for the leak could be found. Flipping the selector switch back to mechanical ventilation mode again, failed to reproduce the leak. In a hurry to begin but unwilling to start a case with a suspected variable leak in the ventilation system we quickly confirmed the availability and functioning of a self-inflating resuscitator-bag and troubleshot one additional time. With the ventilation mode selector switch set to manual mode there was no leak but on switching back to mechanical mode, the large leak reappeared. It was then we noticed that the selector switch did not appear to be at its mechanical limit. Pressure was applied to the lever and it moved to its proper position, causing the leak to disappear. Having established the cause of the variable leak, confirming it could be corrected and having back-up equipment available, we began the case and finished without complication.

The machine was taken out of service following our case our Clinical Engineering group disassembled the machine to identify the nature of the failure mode.. Two actions occur when the lever is turned from bag to machine ventilation: 1) the ventilator is turned on. This does not require the lever to be at its mechanical limit. 2) the bag is isolated from the breathing circuit. This action requires the lever to be at its mechanical limit. Further examination found a viscous build up on the lever that prevented it from reaching its mechanical limit. We speculate the source of this accumulated material was the lubricant for the machine components or cleaning solutions used between surgical cases.

Our case report illustrates the importance of performing the AACR. It is being prepared for publication to notify users of the Aestiva anesthesia machine at other institutions. The manufacturer was notified of this latent error, to allow an engineering solution before a patient comes to harm.

 

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2000 - Cole, Deckinga, Denson, Fuchs, Maples, Naik, Robicsek, R. Zhang

2001 - Denney, Fuchs, Liem, Palacios, Rajasekaran, Rice, Sessions

2002
- Fuchs, Li #1, Li #2, Mayo, Ozcan, Tagalakis,

2003 - Barotti, Barry, Ozcan, Patel, Robinson, Swinney, Tran, van der Heusen , Walters

2004 - Abbasian, Bird, Cahill, Chang, Dahleen, Durret, Horowitz, Perschau, Robinson, Muehlschlegel, Santiago, Velez, Wendling

2005 case reports - Bauernfeind, Cummens, Dagen, Dobija, Yavas

2006 - Book, Chen, Covington, Eisenman, Ficarotta, Hyde, Jordan, Le, Lesko, Moorjani, Muehlschlegel, Seghal, Stine, Tilman