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

Catalog Number 8607000

Device Problems Degraded (1153); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization into examination of the device and did not provide further information upon request.An in-depth investigation is thus not possible.The following general assessment can be made: the most likely interpretation for "bellows" is the manual breathing bag.The manual breathing bag serves as a volume reservoir in both manual and automatic ventilation modes; it must be actuated/squeezed during manual ventilation to provide breathing gas to the patient.It is plausible that e.G.A cut in the surface leads to loss of pressure and volume and may disturb ventilation.The daily pre-use check includes an automatic test procedure through which the device runs autonomously once the user has started it.Further, there is a manual checklist the user has to go through for those test items that cannot be performed by the device independently.For example, during the test of the apl valve it would be obvious if the breathing bag does not fill as intended due to the leakage.Dräger concludes that the damage of the manual breathing bag must have either occurred after full completion of the entire test procedure or the user has not conducted the manual pre-use check or at least only incompletely.It would also be imaginable that the material of the breathing bag became porous after long-term use.Hence, the reported issue is related to aspects that are beyond the control mechanisms a manufacturer can establish.The device has responded as designed upon such deviation and alarmed the divergence between set and delivered tidal volumes.All alarms, potential root causes and dedicated remedies are explained in the ifu.

Event Description

It was reported that the users observed a divergence between set and delivered tidal volumes; the device has posted a corresponding alarm.The users reportedly identified a damage of the "bellows" which made an exchange of the entire anesthesia workstation necessary.This has reportedly caused a delay in the surgery but finally did not lead to health consequences for the patient.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18053501
• MDR Text Key: 327126943
• Report Number: 9611500-2023-00388
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NA.