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

Model Number 1009-9002-000

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, ge healthcare technical support troubleshot the issue with the customer biomed engineer.It was recommended to the customer to complete a full-service calibration and functional test as per the procedures in the technical reference manual and to complete a full pre-op checkout for leaks in the breathing system.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1009-9002-000 anesthesia gas machine experienced a malfunction resulting in the loss of pressure support ventilation.This report was from a single source.This event did not involve a patient.

• 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: 8484923
• MDR Text Key: 141090691
• Report Number: 2112667-2019-00063
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/04/2019

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?: No
• Device Operator: No Information
• Device Model Number: 1009-9002-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/04/2019
• 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: 1