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

Model Number CS2

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

Operating room machine malfunction.No patient harm, - maintained on alternate o2 source.Shortly after induction, noted alarm.The alarm persisted for duration of case.Only able to set flow rate for alternate o2 source.

• Brand Name: AISYS CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 16407765
• MDR Text Key: 309864063
• Report Number: 16407765
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Black Or African American