MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 6 PLUS; VAPORIZER

Model Number 1107-9601-000

Device Problems Defective Alarm (1014); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For this event, ge healthcare's investigation into the reported occurrence is ongoing.A follow-up summary report will be issued when the investigation has been completed.No patient information available after three attempts.Device evaluation anticipated, but not yet begun.

Event Description

This report summarizes 1 malfunction event.A review of the event indicated that model 1107-9601-000 vaporizer ran out of anesthetic agent and did not alarm as intended resulting in light anesthesia.There was no report of patient injury or recall.The report was received from a single source.The reported event did involve a patient.There was no patient information available.

Manufacturer Narrative

The device was not returned for evaluation.No further information available.

• Brand Name: TEC 6 PLUS
• Type of Device: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8544251
• MDR Text Key: 143722945
• Report Number: 2112667-2019-00179
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1107-9601-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1