MAUDE Adverse Event Report: DATEX-OHMEDA, INC TEC 7; VAPORIZER

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2013

Event Type  malfunction  

Event Description

The ge service representative reported the unit's interlock system was not functional.There was no report of patient involvement.

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.

Manufacturer Narrative

The unit was returned to the manufacturing site for investigation.Inspection of the unit revealed the interlocking bushing was installed incorrectly causing malfunction.The mdr was filed following a retrospective review related to a 483 response.

• Brand Name: TEC 7
• 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: 4925106
• MDR Text Key: 6009153
• Report Number: 2112667-2015-00068
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/07/2013

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: 06/17/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2012
• 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