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

Model Number	M1057380
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Serial numbers: (b)(4), 1 serial number unknown.For 1 of the 3 reported events, ge healthcare requested that the unit be returned for repair.Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.For 1 of the 3 reported events, a third party service vendor sent the vaporizer unit to baxter for repair.Baxter declined to return the unit to ge healthcare for evaluation.No further information is available regarding the resolution to the reported issue.For 1 of the 3 reported events, ge healthcare service representative performed a checkout of the system and confirmed the reported events.The vaporizer was recommended for replacement.Other text : device evaluation anticipated, but not yet begun.
Event or Problem Description
This report summarizes 3 malfunction events.A review of the events indicated that model m1057380 vaporizer experienced patient waking up during surgery.These reports were received from various sources.Of the 3 events, 3 did involve patients.There was no patient information available.
Additional Manufacturer Narrative
For 1 of the 3 reported events, requests for the vaporizer return were on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019.Multiple attempts were made to determine the status of the vaporizer return on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019 with no response.At this time, the device owner has not authorized ge healthcare to evaluate the unit.No further information is available.

• Brand Name: TEC 7
• Common Device Name: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8837500
• Report Number: 2112667-2019-00375
• Device Sequence Number: 16215760
• Product Code: CAD
• UDI-Device Identifier: 00840682111508
• UDI-Public: 010084068211150821
• Combination Product (Y/N): N
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M1057380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1