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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESTHESIA UNITS Back to Search Results
Model 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.
 
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 november 2013, a unique device identifier (udi) is not required.
 
Event Description
It was reported that a vent fail occurred during use.There was no patient injury reported.
 
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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 Key18342974
MDR Text Key330802612
Report Number9611500-2023-00477
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042419
Number of Events Reported1
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,Followup
Report Date 07/11/2024
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 Number8606000
Device Catalogue Number8606000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received02/27/2024
02/28/2024
03/05/2024
06/06/2024
Supplement Dates FDA Received02/27/2024
02/28/2024
03/11/2024
07/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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