MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS

Catalog Number 4117110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that there was a fire in the nasal cannula during a case.The users did not allege a device malfunction; they admitted to have used rf surgery equipment which led to the ignition.The patient experienced severe burns and was transferred into a specific clinic for dedicated treatment.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The fabius gs device log file was analyzed for the reported date of event (b)(6) 2019 without finding any suspicious entries which are related to the reported event.The device was tested by a service technician after the event and was found to work according to specification.It was in particular focused on the test results which are related to the o2 adjustment and the associated o2 gas path.As these tests have not revealed any deviations an unintended or unnoticed oxygen supply could be excluded being a factor in the reported event.Additionally it was not alleged by the hospital that the fabius gs has contributed to the reported incident.Most likely the fire was caused by the use of an electro surgical device (electrocautery).Such devices are only used by professionals with a specific training.Based on that it can be assumed that it is basic knowledge that cauterizing close to a source of oxygen can lead to fire.Therefore it should be ensured that all connectors (e.G.Y-piece, breathing hoses including the breathing bag, breathing system) are leak-free so that oxygen leakage cannot endanger the user or the patient.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9206449
• MDR Text Key: 162817799
• Report Number: 9611500-2019-00340
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4117110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization