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

Model Number N/A

Device Problem Fire (1245)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

The device was subject to a full check in follow-up of the event; proper function could be verified.Especially the auxiliary o2 flowmeter was checked, the valve was closing correctly and there was no leakage present.The user facility was not disclosing information whether or not, there was an oxygen flow adjusted at the time the event occurred.It can be considered basic knowledge of trained users that an enriched level of oxygen in a certain environment increases the risk of ignition and fire.The ifu of the auxiliary o2 flowmeter contains an explicit warning that - before cauterizing, the flow meter has to be closed, the mask removed and a few moments have to be passed by to ensure that any oxygen accumulation has dissipated.It seems that the staff did not follow these warnings.Dräger concludes that no malfunction of the workstation or flowmeter has occurred which may have caused or contributed to the event.

Event Description

It was reported that near the end of a case, the anesthesiologist noticed flames coming from the patient's mask.As a result, the patient suffered burns to his/her mouth, hair, and lips.The hospital was contacted and it was determined the patient was not connected to the fabius gs ventilator or under anesthesia, but only the auxiliary o2.Draeger was informed that they were cauterizing during the procedure when the ignition occurred.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6826386
• MDR Text Key: 83838085
• Report Number: 9611500-2017-00257
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Model Number: N/A
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1