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

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Ge is awaiting the return of the malfunctioning vaporizer before beginning an evaluation.A follow-up report will be submitted upon completion of the evaluation.No report of patient involvement.Device evaluation anticipated, but not yet begun.

Event Description

Third party service organization reported that, during routine maintenance, it was noted that the unit's interlock system was not functioning.There was no report of patient involvement.

Manufacturer Narrative

The unit was returned to the manufacturing site for investigation.The unit was tested and the reported complaint was confirmed.During inspection of the unit, it was noted that the interlock plunger pin circlip was missing.The circlip was replaced, resolving the reported complaint.

• 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: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5454022
• MDR Text Key: 39303897
• Report Number: 2112667-2016-00336
• 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: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2016
• 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