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

Patient Problem Insufficient Information (4580)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

During the anesthesia machine daily self-checkout, an "error: set o2 alt flow agent deliver off" message appeared, and the machine failed the self-checkout.The device was connected to the hospital o2 outlet, and there was a full o2 tank connected to the device.Biomed investigated the issue to try and figure out why the device was attempting to use the alternate o2 source.Ge (datex-ohmeda) was called to assess the issue.

• Brand Name: AISYS CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 18169354
• MDR Text Key: 328531333
• Report Number: 18169354
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2023

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
• 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: 09/26/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1