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

Model Number 8604700-48

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

During a surgical procedure the anesthesia machine was having a vent fail.Immediately went to operating room #3 and took the machine from that room to operating room #1 and swapped machines as doctor manually bagged the patient machine was swapped successfully broken machine was tagged and removed from service biomed was then called to report what transpired.

• Brand Name: FABIUS GS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 6 tech drive; andover MA 01810
• MDR Report Key: 16945266
• MDR Text Key: 315388640
• Report Number: 16945266
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8604700-48
• Device Catalogue Number: 8604700-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2023
• Date Report to Manufacturer: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA