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

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The unit was returned to the manufacturing site for investigation.The unit was tested, and the reported complaint was confirmed.It was further noted that the c-clip was missing from the pivot pin.A plunger, pivot pin, and c-clip were installed to correct the issue.

Event Description

The hospital reported that, during routine maintenance testing, 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: stephanie cass ; 3000 n. grandview boulevard; waukesha, WI 53188-1696
• MDR Report Key: 5492682
• MDR Text Key: 40085604
• Report Number: 2112667-2016-00455
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2008
• 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