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

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Further inspection of the unit revealed that the interlock plunger pin and circlip were not in their proper position.Due to the age of the unit, the vaporizer has been scraped.No report of patient involvement.

Event Description

During testing of the unit at the manufacturing site, it was noted that the interlock system was not functioning.There was no report of patient involvement.

• 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
• MDR Report Key: 5519579
• MDR Text Key: 40954199
• Report Number: 2112667-2016-00542
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• 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: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2005
• 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