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

Model Number 1011-9050-000

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Gehc's fe performed a checkout of the aisys cs2 system but could not confirm the reported issue.The device was returned to service.Gehc's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: no patient information provided to date.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Event Description

The hospital reported to ge healthcare (gehc) that a patient was connected to an aisys cs2 when it was alleged that there was a problem with elevated positive end-expiratory pressure.Reportedly, the patient's blood pressure rapidly dropped and the patient was switched to an ambu bag and stabilized.The advanced breathing system was replaced, the patient placed back on the aisys cs2 and the case resumed without incident.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare's gehc) investigation has been completed.Based on the event information, troubleshooting and review of the device logs, it is confirmed that there were high pressure alarms present in both manual and mechanical ventilation.It is unclear whether o2 flush presses contributed to the elevated pressure in manual mode.Gehc field engineer (fe) replaced the adjustable pressure limiting (apl) valve, though this would not resolve elevated pressures in both manual or mechanical ventilation, it was replaced as a precaution.Gehc fe was also unable to duplicate the issue.The machine worked as designed and passed all checkouts.The device logs indicated that while the breathing system was replaced during the case, they also disconnected and reconnected wall supplies.It is possible that the user did not have scavenging connected at the start of the case and connected scavenging when reconnecting the gas supplies.Therefore, the root cause 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: 17010405
• MDR Text Key: 316017311
• Report Number: 2112667-2023-02683
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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: 1011-9050-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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