MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS INC. FABIUS GS PREMIUM; GAS-MACHINE ANESTHESIA

Model Number FABIUS GS PREMIUM

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

Event Type  malfunction  

Event Description

Patient is a (b)(6) year old female that came in for a sleeve gastrectomy.Pt in the operating room the anesthetic vaporizer was turned in the "on" position but it was not delivering any volatile gases.The vaporizer and machine was evaluated.It was found that the vaporizer was full and should have been delivering the gas to the patient.The patient recalls periods of the surgery.The machine and vaporizer was removed from circulation and immediately went for investigation.Dates of use: (b)(6) 2018.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: GAS-MACHINE ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC.
• MDR Report Key: 7544291
• MDR Text Key: 109402444
• Report Number: MW5077451
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FABIUS GS PREMIUM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR