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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A ge healthcare service representative performed a checkout of the equipment.The vaporizer was found to fail leak testing.According to the hospital, the vaporizer has been sent to a third party service organization.

Event Description

Per user filed medwatch report, mw5070188: "crna smelled anesthesia gases and thought it was the pt's airway but could not find a leak.She became dizzy, and asked for another clinician to come into the room.The isoflurane vaporizer was leaking.Vaporizer turned off.Anesthesia tech removed the vaporizer and placed a new one on the machine.After several minutes, the second vaporizer was noted to be leaking.Second clinician took over the case, first clinician put on oxygen by nasal canula and called employee health, treated in the emergency room.Machine, vaporizers, and patient circuit removed and sent to biomed.Another machine was placed on patient.".

• Brand Name: TEC 7
• Type of Device: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6674167
• MDR Text Key: 78609601
• Report Number: 2112667-2017-01195
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 88