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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 08/07/2015

Event Type  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.

Event Description

The hospital reported that the vaporizer was mounted on a non-validated drager anesthesia machine.It was further reported that the vaporizer was plugged into a powermate that was plugged into a wall outlet.The outlet in the powermate was reportedly loose (connection was not secure).The hospital stated that, at some point during the case, the tec 6 power cord was accidentally knocked out of the powermate.According to the electronic medical record (emr), the patient did not receive agent for over an hour.Following the case, the patient reported having recall of the procedure.

Manufacturer Narrative

The hospital reported that, during the case, the vaporizer was plugged into a ¿power mate¿, which was plugged into the wall outlet.The hospital further reported that the outlet in the ¿power mate¿ the vaporizer was plugged into was loose and the connection was not secure.The tec 6 plus manual instructs the user to connect the power cord from the vaporizer to an approved hospital grade outlet socket.The vaporizer was being used on a nonvalidated drager anesthesia machine.The tec 6 plus manual states "the datex-ohmeda vaporizer should be used in anesthesia systems equipped with a selectatec series manifold only".The vaporizer was sent to ge healthcare for investigation.The unit was tested and found to function within manufacturer¿s specifications.

• Brand Name: TEC 6 PLUS
• 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
• MDR Report Key: 5068358
• MDR Text Key: 25440608
• Report Number: 2112667-2015-00147
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K000275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2015
• 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
• Patient Age: 60 YR
• Patient Weight: 189