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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

The hospital reported that, during a case, after placing the patient on their side, the patient was noted to move.The patient was reportedly administered propofol.The vaporizer was set at 7%, and the monitor reportedly read 3.2 %.The clinician reportedly increased the vaporizer dial setting and continued the case.There was no reported patient injury.

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.

Manufacturer Narrative

It should be noted that, according to the tec 7 user reference manual, the tec 7 is only to be mounted on a ge healthcare selectatec manifold.The vaporizer in the reported complaint was mounted on a nonvalidated spacelabs anesthesia machine.A third party service representative performed an output check of the vaporizer and found low output.The vaporizer was returned to the ge healthcare manufacturing site for investigation.The unit was tested, and the output was found to be within published specifications.

• Brand Name: TEC 7
• Type of Device: ANESTHESIA 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: 4377332
• MDR Text Key: 5260038
• Report Number: 2112667-2015-00001
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2012
• 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: 23 YR
• Patient Weight: 81