MAUDE Adverse Event Report: GE HEALTHCARE TECHNOLOGIES, INC. / DATEX-OHMEDA, INC. ANESTHESIA CART; GAS-MACHINE, ANESTHESIA

Model Number AISYS CS2

Patient Problems Cyanosis (1798); Brain Injury (2219)

Event Date 12/23/2023

Event Type  Death  

Event Description

Anesthesiologist had trouble with high peep(positive end-expiratory pressure) throughout procedure and had to bag patient intermittently.Although oxygen saturation remained at 100% throughout procedure, the patient did not wake up.Ct(computed tomography) results a few hours after procedure showed anoxic brain injury.

• Brand Name: ANESTHESIA CART
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE TECHNOLOGIES, INC. / DATEX-OHMEDA, INC.
• MDR Report Key: 18445117
• MDR Text Key: 332143189
• Report Number: MW5149764
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AISYS CS2
• Device Catalogue Number: 1011-9050-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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