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

Model Number FABIUS GS

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/23/2017

Event Type  malfunction  

Event Description

A patient required general anesthesia for a cesarean section.The anesthesia machine had undergone the appropriate leak test that morning and had passed the test.When pre-oxygenating the patient, it was noted that even though the digital screen was reading 11 liter/min flow of oxygen, the bobbin in the flow ever was not floating, indicating that oxygen was not flowing as expected.

• Brand Name: FABIUS GS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 6431416
• MDR Text Key: 70818702
• Report Number: 6431416
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FABIUS GS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2017
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES.; NO OTHER THERAPIES
• Patient Age: 37 YR