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

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the sevoflurane anesthetic gas cassette was removed and refilled during a case.Upon re-installing the cassette to the anesthesia machine, agent delivery did not resume at the previous level.Sevoflurane remained off for 33 minutes.No alarms alerted the users that sevoflurane was not being delivered.Upon discovery, the sevoflurane was turned back on and more propofol was given to re-anaesthetize the patient.Upon waking after the case, the patient voluntarily disclosed recollection of waking up during the procedure.The patient is undergoing regular psychological appointments.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation of this event.The patient had elevated heart rate and blood pressure 30 minutes after the anesthetic agent cassette was removed.The anesthetic agent was sevoflurane and the setting leading up to the event was set at 2.0%.Based on the log entries, the sevoflurane cassette was removed at 18:30:45 (alarm triggered on, "insert cassette") and the agent setting is set to 'off' automatically since it was removed from the device.Roughly 45 seconds later, a sevoflurane cassette was inserted at 18:31:24 (alarm triggered off, "insert cassette" alarm removed).A tone sounded, and the quick key menu opened.The agent setting flashed yellow repeatedly for 30 seconds alerting the user that the anesthetic agent delivery was set to 2.0% and was currently â offâ prompting the user for confirmation.Precisely 30 seconds after the "insert cassette" alarm was removed, the quick key menu timed out as designed at 18:31:54.Based on this information, the user did not confirm, so the anesthetic agent setting remains 'off'.20 minutes later, the next log entry noted that the o2% was changed.The anesthesia machine does not make clinical decisions and with the cassette being inserted, the clinician must evaluate if the previous setting is still appropriate for the patient.Patient is undergoing regular psychology appointments as a result of this event.The root cause of this event is that the user did not properly follow the steps to insert a cassette or replace a cassette and did not react to the audible or visual cues from the device that indicate the user needs to take action.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 10693906
• MDR Text Key: 212295027
• Report Number: 2112667-2020-02872
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other