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

Model Number AVANCE S5

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

Machine displays "set alt o2 flow! check agent setting.".

• Brand Name: AVANCE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 10605578
• MDR Text Key: 209143095
• Report Number: 10605578
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVANCE S5
• 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: 09/16/2020
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1