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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); Decrease in Pressure (1490); Reset Problem (3019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that during use, when the user pressed the switch to change the settings, the screen went black and the device restarted.After that, the device worked normally and the surgery was continued.No injury reported.
 
Manufacturer Narrative
The analysis of the device log has shown that on the date of event the device performed a software reboot.This event is logged if the cpu is reset due to a expired watchdog timer.In case this safety function is triggered the ventilator stops working.This is accompanied by an acoustical alarm and is also visible as the screen turns black.Subsequently, a self-test is performed by the device also containing a test of the loudspeaker what is audible for the user.After completion of the test the device switches to man/spont mode.As the requested parts were not provided for investigation finally, the root cause of the identified software reboot could not be identified.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that during use, when the user pressed the switch to change the settings, the screen went black and the device restarted.After that, the device worked normally and the surgery was continued.No 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
MDR Report Key13947871
MDR Text Key293839110
Report Number9611500-2022-00067
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
Report Date 05/19/2022
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? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/18/2022
Initial Date FDA Received03/30/2022
Supplement Dates Manufacturer Received05/10/2022
Supplement Dates FDA Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2013
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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