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

Model Number 1009-9002-000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Serial number: (b)(4).For 3 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The ez change valve and o-rings were replaced to resolve 1 reported event, the co2 bypass housing assembly valve and o-rings were replaced to resolve 1 reported event, and the breathing system expiratory valve, flow sensors, and scavenger valve were cleaned to resolve 1 reported event.For 1 reported event a ge healthcare service representative performed a checkout of the system and did not confirm the reported event.For 1 reported event, the customer declined ge healthcare repair recommendation.

Event Description

This report summarizes 5 malfunction events.A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced unexpected therapeutic results.The 5 events were reported for malfunction resulting in elevated co2 readings.These reports were received from various sources.Of the 5 events, 3 did not involve a patient, and 2 did involve patients.There was no patient information available.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8487547
• MDR Text Key: 141205960
• Report Number: 2112667-2019-00070
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Device Operator: No Information
• Device Model Number: 1009-9002-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0