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

Model Number 1107-9601-000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, ge healthcare requested that the unit be returned for repair.Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Other text : 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 experienced a mechanical problem.It was reported that two vaporizers could be turned on at the same time.This report was received from a single source.The reported event did not involve a patient.

Manufacturer Narrative

The device owner has not authorized ge healthcare to evaluate the unit.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: 8837351
• MDR Text Key: 175034816
• Report Number: 2112667-2019-00373
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1107-9601-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1