MAUDE Adverse Event Report: DATEX-OHMEDA INC / GENERAL ELECTRIC CO. GENERAL ELECTRIC AVANCE CS2; GAS MACHINE ANESTHESIA

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

This concerns a theoretical safety issue regarding an anesthesia machine, the ge avance cs2.This anesthesia workstation is equipped with a touchscreen controlled ventilator, but any settings made on the touchscreen with the intent to start the ventilator must be followed by the throwing of a mechanical lever behind the touchscreen.More than one board certified, moca-current anesthesiologist has believed the ventilator to be working only to discover that such was not the case because the lever behind the screen was not in the proper position.Stated another way, if the pt is apneic when the ventilator settings are entered for anything but assisted ventilation and the relatively hidden lever is not thrown, the pt will remain apneic.If alarms had been inactivated prior to entering the ventilator settings, they will remain inactivated after the ventilator settings are entered, and the pt will remain apneic.If pts are hypo-ventilating prior to entering the ventilator settings, they will continue to do so after the ventilator settings are entered unless the out of sight switch is thrown.One change that could lessen the likelihood of human error with this design would be to after the color of the background of the currently gray ventilator setting buttons.If the background of the ventilator buttons change to green when the lever was set to utilize the ventilator, the ventilated status could be easily confirmed visually by the anesthesia provider.If the background of the ventilator setting buttons was red when the ventilator was, as a result of the lever position, inactivated, the non-ventilated status would be easily visible to the anesthesia provider by the red colored buttons relative to the green.Attempts have been made to contact ge directly regarding this safety concern.To date, no response has been received.

• Brand Name: GENERAL ELECTRIC AVANCE CS2
• Type of Device: GAS MACHINE ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC / GENERAL ELECTRIC CO.
• MDR Report Key: 6653070
• MDR Text Key: 78089777
• Report Number: MW5070490
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1