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

Model Number 8606000

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189); Unexpected Shutdown (4019)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that ventilation failed during operation without alarm and error message.Device has stopped ventilation.After a restart, the device ran without errors or problems.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the logfile analysis, one entry was found indicating that an overpressure condition occurred.The code was logged because the measured airway pressure was more than 10mbar above the pmax limit adjusted by the user for more than 20ms.In this case, the ventilator motor performs a zeroing maneuver for the piston position which is not visible for the user and does not lead to an impact on the ventilation performance in case the overpressure situation recovers within 400ms.This was the case here, as otherwise another code would have been logged.The fabius is equipped with an integrated pressure- and flow monitoring ensuring that deviations from set/expected parameters are obvious for the user and alarmed according to the alarm limits adjusted.The fabius will alarm for airway pressure high.If the upper alarm limit for the airway pressure was exceeded, depending on the adjusted upper peak alarm limit.It was further reported that after the case in question the device ran for 12 hours without any issues and the device passed testing without any problems found.Based on that and the fact that the found code is a software protection function and no malfunction with the device, it can be assumed that the described symptom appeared because of a coughing or moving patient.Dräger finally concludes that the workstation responded as designed upon the detected overpressure situation.Either this has been mistakenly perceived by the user as a vent fail or e.G.A leak was present explaining the reported issue.All in all, there were no entries in the logs that would explain the reported ventilation failure without any alarm.An explanation for observed problems in ventilation would be that the delivered volume had escaped to ambient via a leakage in the patient circuit.It cannot be derived from the available information if a leakage was present and if yes - where exactly this leak was located.However, an alarm would have been given by the device accordingly.Finally, the reported symptom could not be reconstructed but it could be concluded that it was not related to a device malfunction.

Event Description

It was reported that ventilation failed during operation without alarm and error message.Device has stopped ventilation.After a restart, the device ran without errors or problems.No patient injury reported.

Event Description

It was reported that ventilation failed during operation without alarm and error message.Device has stopped ventilation.After a restart, the device ran without errors or problems.No patient injury reported.

Manufacturer Narrative

This is a correction of the previous report.The model no.Was corrected.As the affected fabius tiro, serial no.(b)(6), was produced in september 2008, a unique device identifier (udi) is not required.

• 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: 18197880
• MDR Text Key: 328899479
• Report Number: 9611500-2023-00443
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606000
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/23/2023
• Supplement Dates Manufacturer Received: 11/24/2023; 06/06/2024
• Supplement Dates FDA Received: 01/29/2024; 08/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2008
• 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