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

Model Number CS2

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

During the case, the ventilator alarmed "sensor failure" causing the vent not to work properly.The crna (certified registered nurse anesthetist) switched the machine to manual ventilation and was easily able to ventilate.The anes.Tech was called to the room to exchange the machine.During the exchange, the patient was ventilated with an ambu bag with auxilllary o2.The patient remained sedated/anesthetized the entire time.Once the original machine was moved, water was observed coming from the bottom of the machine.The service tech was notified and will come as soon as possible.Manufacturer response for anesthesia machine, ge advance cs2 (per site reporter) ge notified.Service tech will evaluate asap.

• Brand Name: AVANCE CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 18363353
• MDR Text Key: 330979230
• Report Number: 18363353
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2
• Device Catalogue Number: 1009-9050-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Female