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 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The unit was returned to ge healthcare for investigation.The unit was inspected and it was noted that the interlock rod assembly was missing.

Event Description

While testing the unit at the service depot facility, it was noted that the interlock system was not functioning.

• 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
• MDR Report Key: 5313365
• MDR Text Key: 33966389
• Report Number: 2112667-2015-00411
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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