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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to ge healthcare for investigation.The unit was inspected and it was noted that the interlock plunger pin circlip was missing.The part was replaced and the unit is operational.

Event Description

During routine installation testing, the ge healthcare service representative noted the interlock system was not functional.There was no 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: 5317745
• MDR Text Key: 34128424
• Report Number: 2112667-2015-00441
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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