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

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2012

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

During a distributor inspection, it was reportedly noted that the interlock system was not functioning.There was no report of patient involvement.

Manufacturer Narrative

The unit was returned to the manufacturing site for investigation.Inspection of the unit revealed interlock retaining screws were missing.The mdr was filed following a retrospective review related to a 483 response.

• 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 60010-3076 ; 8472774719
• MDR Report Key: 4925198
• MDR Text Key: 22445471
• Report Number: 2112667-2015-00065
• 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: distributor
• Reporter Occupation: Biomedical Engineer
• Report Date: 04/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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: 05/18/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1