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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
Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 04/16/2022
Event Type  malfunction  
Event Description
It was reported that the ventilation failed during use. No patient consequences have been reported. Remark: based on an initial log file analysis, the case was first assessed as not reportable since the error codes indicated only a disturbance of ventilation and not a complete stop. Evaluation of the returned hardware revealed later-on that indeed the ventilation had stopped as reported.
 
Manufacturer Narrative
The dispatched fse has exchanged the control board of the device; the workstation passed all tests afterwards and could be returned to use. The replaced board was returned to manufacturer for evaluation. It could be confirmed that the board was not functional; the root cause could be traced back to the malfunction of a single electronic component (z diode). The consequence was that - among other impairments - the calibration of the pressure sensors was not possible anymore. The device is designed to shut-down automatic ventilation in such case since the protection against potentially hazardous output does not work anymore without airway pressure measurement. The user is alerted to this condition by means of a corresponding alarm; manual ventilation with the built-in breathing bag remains possible. Dräger finally concludes that the device responded as designed to the particular error condition. The malfunction of a single electronic component after almost 12 years of use can be considered acceptable.
 
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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 Key15189923
MDR Text Key302941001
Report Number9611500-2022-00201
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
Report Date 08/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2010
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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