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

Catalog Number 8606000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that a vent fail occurred during use.There was no patient injury reported.

Event Description

It was reported that a vent fail occurred during use.There was no patient injury reported.

Manufacturer Narrative

Based on the analysis of the electronic logfile, the case in question could be reconstructed.The log entries indicate that a combination of a fresh gas deficit with an improperly opening auxiliary air intake valve has caused a ventilator failure.During downward movement of the piston, the device detected that a negative pressure has been built-up to a certain level which is an indication for a fresh gas deficit.Such fresh gas deficit can be caused by an unsuitable fresh gas setting and/ or leakages in the patient circuit.The log entries do not allow for a more detailed analysis regarding the exact root cause.The fabius is designed to open an auxiliary air intake valve on top of the ventilator to compensate the fresh gas deficit with ambient air.According to the log, the compensation did not happen as expected indicating that the movement of the auxiliary air intake valve was restricted.The negative pressure further increased and the fabius finally reacted as specified by temporarily stopping the piston movement and generating a ventilator failure alarm.In such case ventilation will resume automatically once the pressure is within the accepted range.It can be concluded that a sticking or delayed opening auxiliary air intake valve has caused the reported symptom.Based on experience this is caused by insufficient reprocessing (in particular drying).Traces can hardly be determined afterwards as the humidity will likely evaporate quickly.Dräger finally concludes that the fabius device has reacted as specified for the detected deviation.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Manufacturer Narrative

The investigation is still ongoing.The result will be forwarded after investigation was closed.

Event Description

It was reported that a vent fail occurred during use.There was no patient injury reported.

Manufacturer Narrative

Within the first follow-up report sent 2024-02-27, wrong imdrf codes were provided.This second follow-up report is sent to correct the imdrf codes.The investigation is still ongoing.The result will be forwarded after investigation was closed.

Event Description

It was reported that a vent fail occurred during use.There was no patient injury reported.

• Brand Name: FABIUS TIRO
• 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: 18342974
• MDR Text Key: 330802612
• Report Number: 9611500-2023-00477
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• 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,Followup,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NA.; NA.; NA.; NA.