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

Model Number 1011-9050-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyanosis (1798)

Event Date 12/23/2023

Event Type  Death  

Event Description

Per medwatch mw5149764, it was reported that, "anesthesiologist had trouble with high peep throughout procedure and had to bag patient intermittently.Although oxygen saturation remain at 100% throughout procedure, the patient did not wake up.Ct results a few hours after procedure showed anoxic brain injury." ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block d4 unique identifier: (b)(4).Block g2 report source other: medwatch report # mw5149764 legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718 h3 other text : device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Ge healthcare's (gehc) investigation has been completed.The gehc's field engineer completed a review of the system logs and checkout of the device and determined there was no malfunction of the gehc device.The root cause of the alleged insufficient gas flow cannot be determined.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18649293
• MDR Text Key: 334618853
• Report Number: 2112667-2024-00657
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American