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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

The hospital reported 2 vaporizers were delivering agent at the same time.There was no patient injury.

Manufacturer Narrative

Customer contact reports there is no patient information available.(b)(4).

• Brand Name: TEC 6 PLUS
• Type of Device: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 12816883
• MDR Text Key: 286251162
• Report Number: 2112667-2021-02532
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1