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U.S. Department of Health and Human Services

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

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DRAEGER MEDICAL SYSTEMS, INC. FABIUS GS PREMIUM GAS-MACHINE, ANESTHESIA Back to Search Results
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.

 
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Brand NameFABIUS GS PREMIUM
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC.
3135 quarry rd.
telford PA 18969
MDR Report Key7741826
MDR Text Key115775082
Report Number7741826
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2018
Device Age10 yr
Event Location Hospital
Date Report TO Manufacturer08/02/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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