MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 850; VAPORIZER

Model Number 1177-9850-SEV

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information available at time of mdr filing.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that during the first use of this vaporizer toward the end of the case, the patient experienced hypertension and coded.The patient was stabilized and is reported to be alright now.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation of this event.Low agent output was reported in testing at the customer site, and although it was confirmed that this efficacy testing was performed on a non-ge (mindray) anesthesia machine, the vaporizer was returned to ge healthcare for further testing.The vaporizer was tested by ge healthcare product engineering and found agent output to be within specification.There is no evidence of a malfunction or defect of this vaporizer.The investigation determined that the customer used this vaporizer outside of its intended use on a non-ge (mindray) anesthesia machine.This caused improper sealing of the vaporizer.This vaporizer is designed and mitigated for proper sealing to a ge healthcare selectatec manifold only.The tec 820/850 user's reference manual states explicitly that "the vaporizers are not designed to be used on any other manufacturer's anesthesia machine." the root cause was determined to be improper use outside of its intended use on a non-ge anesthesia machine.The patient recovered after this event.

• Brand Name: TEC 850
• Type of Device: VAPORIZER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8573188
• MDR Text Key: 143821120
• Report Number: 2112667-2019-00183
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K172702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1177-9850-SEV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1