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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 Consequences Or Impact To Patient (2199)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
The device is approximately 5 years old and not under a service contract; the maintenance status is unknown.Dräger was seeking for additional information but the only aspect that could be obtained was that the device is back in use after exchange of a filter which was performed by the hospital's biomedical engineer.A case specific-evaluation is not possible due to lack of information.The device is equipped with a vacuum pump that generates an auxiliary vacuum pressure which is needed to actuate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.The system effect of an occluded inlet filter for the vacuum pump is that the pump cannot build-up the necessary pressure upon which the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.It is recommended by dräger to check the workstation in regular intervals.Inspection of the inlet filter and replacement based upon visual appearance are part of the service and maintenance procedure, a replacement of the filter shall be done at least every two years.Given that the reported issue "stopped working" can be considered a shutdown of automatic ventilation.This may have been caused by an occluded filter of the vacuum pump.If so, it is seen likely that the maintenance recommendations were not followed and finally led to the particular ventilator failure during use.A reliable conclusion about the root cause is however not possible based on the few confirmed facts.
 
Event Description
It was reported that the device "stopped working" during a running surgical procedure.No patient consequences have been 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 23542
GM  23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key11130458
MDR Text Key228229097
Report Number9611500-2021-00005
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 company representative,user f
Type of Report Initial
Report Date 01/07/2021
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 Catalogue Number8606000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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