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

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Anesthesia questioned if ge datex-ohmeda tec 7 anesthesia vaporizer was delivering appropriate amount(s) of medication.

• Brand Name: TEC 7
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 12083429
• MDR Text Key: 258910955
• Report Number: 12083429
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Date Report to Manufacturer: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA