MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE

Model Number 1006-9321-000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported event was addressed by the distributor performing a checkout and adjustment of the gas proportioning system.No further resolution information available.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1006-9321-000 anesthesia gas machine experienced the gas proportioning system not operating as expected, causing the potential of a hypoxic mix of gas delivery.This report was from a single source.This event did not involve a patient.

• Brand Name: AESTIVA 7100
• 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: 8477850
• MDR Text Key: 145279875
• Report Number: 2112667-2019-00044
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1006-9321-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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