MAUDE Adverse Event Report: DATEX-OHMEDA INC. TEC 7; VAPORIZER

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

The hospital reported that, during a case, it was taking more anesthetic agent to sedate the patient than what the vaporizer concentration dial was showing.There was no reported patient injury.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and found output low to manufacturing specifications.The unit was returned to the manufacturing site for investigation.The unit was tested and found to function within published specifications.

• Brand Name: TEC 7
• Type of Device: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 5008709
• MDR Text Key: 24128384
• Report Number: 2112667-2015-00103
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 109