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

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 10/04/2022

Event Type  Injury  

Event Description

The hospital reported that a patient was connected to an advance when it was alleged that the patient experienced bronchospasm and subsequent cardiac arrest.Reportedly, ketamine and salbutamol were administered to relieve bronchospasm and the patient was resuscitated via cpr and administration of 1mg adrenaline.The case was canceled, and the patient was transferred to post operative recovery.The patient recovered and was discharged home.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare as investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Manufacturer Narrative

The end user completed an investigation and shared the results with ge healthcare.The root cause of the excessive pressure was a use error of connecting the expiratory limb of the breathing circuit to the auxiliary common gas outlet (acgo).There was no malfunction.

• Brand Name: AVANCE
• 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: 18495562
• MDR Text Key: 332686531
• Report Number: 2112667-2024-00248
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2013
• 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
• Patient Age: 43 YR
• Patient Sex: Female