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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare (gehc) service representative performed a checkout of the equipment.It was reported to gehc that the vaporizer was plugged into the wall and not the anesthesia machine.When the anesthesia machine was moved, the vaporizer unknowingly became unplugged from the wall.It is unknown when the vaporizer became unplugged.During the reported case, the vaporizer was able to be turned on without being powered on.The vaporizer was replaced.The customer contact reported there was no further patient information available.

Event Description

The hospital reported that the patient's blood pressure and heart rate were noted to be higher than expected.The clinician switched to another anesthetic agent.There was no reported patient injury.

Manufacturer Narrative

The unit was returned to ge service center.Ge technician evaluation found no fault with the returned unit.

• Brand Name: TEC 6 PLUS
• Type of Device: VAPORIZER
• 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: 7923242
• MDR Text Key: 122308235
• Report Number: 2112667-2018-01916
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• 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