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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 Problem 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.
 
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Brand NameFABIUS TIRO
Type of DeviceANESTHESIA 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
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606000
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? No
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

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