TEC 7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-08 for TEC 7 manufactured by Datex-ohmeda, Inc..

Event Text Entries

[92068898] A ge healthcare service representative performed a checkout of the equipment and confirmed the vaporizer dial was broken. The vaporizer was sent for repair of the dial. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
Patient Sequence No: 1, Text Type: N, H10

[92068899] The hospital reported they had insufficient agent delivery to an animal patient. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2112667-2017-02086
• MDR Report Key: 7009519
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2017-11-08
• Date of Report: 2017-11-08
• Date of Event: 2017-10-10
• Date Mfgr Received: 2017-10-10
• Device Manufacturer Date: 2011-02-07
• Date Added to Maude: 2017-11-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JOHN SZALINSKI
• Manufacturer Street: 540 W. NORTHWEST HIGHWAY
• Manufacturer City: BARRINGTON IL
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TEC 7
• Generic Name: VAPORIZER
• Product Code: CAD
• Date Received: 2017-11-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DATEX-OHMEDA, INC.
• Manufacturer Address: 3030 OHMEDA DR, MADISON, WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-11-08