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

Device Problem Misconnection (1399)

Patient Problem Low Cardiac Output (2501)

Event Date 10/13/2021

Event Type  Injury  

Event Description

The hospital reported a misconnection of the expiratory limb of the breathing circuit to the common gas outlet caused inability to vent inspired gases, and subsequent intrathoracic pressure resulting in decreased venous return and fall in cardiac output requiring 3 minutes of cpr.The misconnection was detected, and the expiratory limb was placed onto the correct connection.Normal ventilatory parameters were restored.The patient was transferred to the intensive treatment unit and made a complete recovery.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcareâs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information.Legal manufacturer: hcs madison - (b)(4).

Manufacturer Narrative

The customer identified the root cause of the increase in the patientâs intrathoracic pressure was caused by the user when the expiratory limb of the breathing circuit was misconnected to the auxiliary common gas outlet (acgo).There was no device malfunction.

• 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: 14306762
• MDR Text Key: 290918991
• Report Number: 2112667-2022-01140
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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): Required Intervention