MAUDE Adverse Event Report: DRAGERWERK AG & CO. KGAA FABIUS GS; GAS-MACHINE, ANESTHESIA

Model Number 8604699

Device Problems Defective Alarm (1014); Defective Device (2588)

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

Event Date 10/29/2020

Event Type  malfunction  

Event Description

During a robotic surgical case, the anesthesia machine in or 4 was noticed that the co2 on the screen was no longer active.The anesthesia machine had a flashing light but no alarm to indicate that the ventilator failed.We moved the anesthesia machine from or3 to or4 to be used for the remainder of the case.There was no harm to the patient.Pt was manually ventilated while the machines were changed.Machine out of rotation to biomed to be fixed.

• Brand Name: FABIUS GS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAGERWERK AG & CO. KGAA; 3135 quarry road; telford PA 18969
• MDR Report Key: 10835629
• MDR Text Key: 216175487
• Report Number: 10835629
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

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?: Yes
• Device Operator: Other
• Device Model Number: 8604699
• 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: 11/11/2020
• Device Age: 12 YR
• Date Report to Manufacturer: 11/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA