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

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2014

Event Type  malfunction  

Manufacturer Narrative

No report of pt involvement.Bock e: the initial reporter is located outside the u.S., and therefore this info is not provided due to country privacy laws.The unit was not returned to the mfg site for investigation.An exact root cause cannot be determined.

Event Description

The hospital reported noted the interlock system was not functional.There was no report of pt 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: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4938346
• MDR Text Key: 22660438
• Report Number: 2112667-2015-00080
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K000275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2003
• 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