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

Device Problems Device Difficult to Program or Calibrate (1496); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954); Program or Algorithm Execution Problem (4033)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Ge datex-ohmeda aisys cs2 anesthesia machine.After refilling the vaporizer the device requires the user to touch the flashing button on the touch screen to resume anesthetic administration at the previous setting.If the user fails to touch the screen administration of inhalation anesthetic ceases.In this case, the patient began to awaken and move during surgery because the default was to turn off the vaporizer.This is a critical design flaw and could have resulted in patient awareness under surgery.There is no reason that the default should be to turn off the anesthetic, as opposed to resuming the previous setting.At a minimum, a continuous alarm should sound until the user engages.Luckily there was no adverse event (no patient recall) because the error, once discovered, was addressed by quickly turning the anesthetic back on and administration of a dose of iv anesthetic.Had the provider instead managed the patient's movement by administration of a paralytic agent (as often happens during anesthetics), the result could have been most unfortunate.

• Brand Name: AISYS CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GENERAL ELECTRIC / DATEX-OHMEDA, INC.
• MDR Report Key: 16743676
• MDR Text Key: 313412692
• Report Number: MW5116638
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male