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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
Catalog Number 8606000
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Manufacturer Narrative
A dräger service engineer was dispatched who examined the device but could not duplicate the issue; the machine did not exhibit any malfunction, passed all tests and was returned to use.The data recorded in the log file confirms the reported ventilator failure and indicates that the ventilator shut-down was related to a drop of the auxiliary vacuum pressure.The auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the vacuum pump cannot build-up the necessary pressure the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm since a dislocated or wrinkled piston diaphragm may cause significant mechanical damages to the ventilator unit.Reasons for a drop of vacuum pressure can be multiple; a pump issue, an occluded inlet filter, a leakage in the device-internal tubing; perforation of the ventilator diaphragm and many more.Most of these scenarios would be reproducible during follow-up testing due to persisting nature of the technical error condition.From the fact that the device did not exhibit any issues during testing can be concluded that the vacuum loss was related to a temporary leakage only.Dräger finally concludes that the workstation responded as designed upon a deviation that was triggered by a temporary condition of unknown origin ¿ a ventilator shutdown was forced and, the user was alerted to this by means of a corresponding alarm.Manual ventilation with the built-in breathing bag remains possible.
 
Event Description
It was reported that the device posted a vent fail message during use; patient support was continued in manual ventilation until a replacement device was made available.No patient consequences have occurred.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
Event Description
It was reported that the device posted a vent fail message during use; patient support was continued in manual ventilation until a replacement device was made available.No patient consequences have occurred.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3: not returned to manufacturer.
 
Event Description
It was reported that the device posted a vent fail message during use; patient support was continued in manual ventilation until a replacement device was made available.No patient consequences have occurred.
 
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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
MDR Report Key12859859
MDR Text Key283819935
Report Number9611500-2021-00473
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8606000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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