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

Device Problems No Device Output (1435); Ventilation Problem in Device Environment (3027)

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

Event Date 07/17/2018

Event Type  malfunction  

Event Description

Patient brought to the operating room for laparoscopic cholecystectomy.During the procedure, the anesthesia machine showed "ventilator failure" on the main screen.The patient was taken off of the ventilator and a manual resuscitator bag was used to maintain respirations.Anesthesiologist was able to restart the machine and perform a safety check.No issues were found and the patient was placed back on the anesthesia machine without any further complications.Clinical engineering was notified immediately of the incident and have removed the machine from service.No patient harm.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 7741826
• MDR Text Key: 115775082
• Report Number: 7741826
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1