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

Catalog Number 8607000

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 09/18/2018

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 flame coming from a surgical instrument being used by the doctor during a case.The patient was injured by the flame.Further details regarding the injury are not available.The customer confirmed that there was no failure with the fabius anesthesia workstation.However a use error in connection with the setting of o2-concentration appropriate for esu application cannot be ruled out at this time.

Manufacturer Narrative

The users did not allege any malfunction of the fabius but the workstation was tested by a draeger service technician in follow-up of the event whereby it could be confirmed that the unit is free of faults; all tests including electrical safety and leakage were passed w/o deviations.It can be considered basic knowledge of a person being trained on performing rf surgery that cauterization in an oxygen enriched environment may result in ignitions and/or combustions.The ifu of the fabius contains a dedicated warning for risk of fire - the user is advised to stop the o2 flow, to the remove mask and to wait a few moments before activation of the rf surgery instrument that the oxygen dissipates.It can be assumed that the ifu of the esu or other rf equipment contains similar warnings, too.It is finally concluded that the reported event was a consequence of user disregarding the dedicated warnings.There is no issue with the fabius that would require repair or correction; the device did not cause or contribute to the patient outcome.

Event Description

Please refer to initial mfr.Report #9611500-2018-00322.

• Brand Name: FABIUS GS PREMIUM
• 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: 7937562
• MDR Text Key: 122792657
• Report Number: 9611500-2018-00322
• Device Sequence Number: 1
• Product Code: BSZ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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 Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2013
• 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
• Patient Outcome(s): Life Threatening