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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the fabius anesthesia machine posted a ventilator failure alarm during use.There was no injury reported.

Event Description

It was reported the fabius anesthesia machine posted a ventilator failure alarm during use.There was no injury reported.

Manufacturer Narrative

Dräger established follow-up communication with the hospital's biomed who reported back that he could identify the root cause for the problem: the control tubes for the apl bypass and peep valves were pinched underneath the cover of the breathing system.After removing this by routing the tubes correctly through the dedicated slots the problem could be rectified.No parts were replaced, no photo of the state at the time of event was available and no logs were provided.The most likely explanation would be the following: peep and apl bypass valve are actuated pneumatically via small tubes; occlusion of these tubes or leakeages therein may lead to significant leakages thus, to impairments of the ventilation.Depending on the level of disturbance the device may shut-down automatic ventilation.If the error condition is present at the time of the pre-use check already this will be detected and alarmed.The cover of the breathing system has to be removed for reprocessing.It is seen likely that the control tubes were not guided correctly through the dedicated slots during reassembly afterwards.One similar complaint is known at an installed base of approx.15.000 machines.Dräger finally concludes that the workstation responded as designed upon an error condition which is related to installation error after reprocessing.No patient consequences have been reported.

• 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
• MDR Report Key: 10362440
• MDR Text Key: 201550071
• Report Number: 9611500-2020-00268
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1