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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607000
Device Problems Use of Device Problem (1670); No Pressure (2994)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
It was reported that the pressure waveform did not appear during use.The procedure was continued in manual ventilation.After returning to mechanical ventilation, it worked without problems.No injury reported.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-u report.
 
Manufacturer Narrative
The device log was analyzed for the case in question without revealing any conspicuous entries.Only the entry that the device was powered on that day was registered.Therefore, the reported symptom of a disappeared pressure waveform could not be comprehended and finally a root cause could not be determined.During on-site evaluation the symptom was also not reproducible.In general, a leakage within the ventilator or in the breathing circuit are conceivable explanations for the reported symptom.As the symptom reportedly could not be observed anymore after the device was switched to manual and back to automatic ventilation a possible leakage maybe was troubleshooted during this process and handling.The fabius is equipped with an integrated pressure and volume monitoring.The breathing pressure monitoring windows show the breathing pressure information in numeric and graphic form.A disappeared pressure waveform is obvious for the user.During automatic ventilation "apnea" alarms are generated if the breathing pressure monitor and / or the respiratory volume monitor does not sense a valid breath for a specified period.Automatic ventilation is continued.
 
Event Description
It was reported that the pressure waveform did not appear during use.The procedure was continued in manual ventilation.After returning to mechanical ventilation, it worked without problems.No injury reported.
 
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Brand Name
FABIUS GS PREMIUM
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 Key13974586
MDR Text Key294656045
Report Number9611500-2022-00084
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K011404
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 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8607000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2013
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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