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

Model Number 1009-9050-000

Device Problem Inaccurate Delivery (2339)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/10/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to an avance cs2 when mechanical ventilation reportedly did not work.Reportedly, the patient desaturated.There was no patient injury.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.Unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Ge healthcares (gehc) investigation has been completed.The gehc's field engineer completed a review of the system logs and checkout of the device.The root cause of the alleged loss of ventilation and intermittent ventilation failures after intubation cannot be determined, though it is possible that improper placement of the endotracheal tube, end user customer skipping the checkout procedure, or an inconsistent connection or seating of components between the canister and easy change module due to worn/dirty components contributed to insufficient ventilation.Therefore, the root cause cannot be determined.

• Brand Name: AVANCE 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: 16320802
• MDR Text Key: 309012613
• Report Number: 2112667-2023-00568
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9050-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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 Sex: Male