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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH FABIUS PLUS ANESTHESIA WORKSTATION

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DRAEGER MEDICAL GMBH FABIUS PLUS ANESTHESIA WORKSTATION Back to Search Results
Device Problems Seal (432); Ring (943); False Reading From Device Non-Compliance (1228); Component Missing (2306)
Patient Problem Stroke/CVA (1770)
Event Date 07/11/2012
Event Type  Injury  
Event Description

It was reported that a patient was ventilated with the anaesthesia machine fabius plus and the physician recognized a big deviation between the co2 values measured by a nihon kohden patient monitor and the values given by the blood gas analysis. The physician believed in the values of the monitoring system but the patient state of health got worse. It was reported the patient received a brain infarction. An onsite investigation revealed that a missing seal ring at the carbon dioxide absorbance container caused bypass the co2 absorber.

 
Manufacturer Narrative

The instruction for use of the fabius plus requires an appropriate co2 monitoring. For that purpose the nihon kohden monitor (b)(4) was used. This monitor uses a so called auto zero function for the inspiration phase. To detect the increase of inspiratory co2 concentration this function is disadvantageous. Drager monitor systems do not use this functionality since many years. However, the monitor indicated an etco2 value of about 15mmhg which clearly indicates inadequate ventilation or metabolism of the patient. The clic adapter involved in the event was requested for investigation. Further information will be reported in the follow-up report.

 
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Brand NameFABIUS PLUS
Type of DeviceANESTHESIA WORKSTATION
Manufacturer (Section D)
DRAEGER MEDICAL GMBH
moislinger allee 53-55
lubeck 2354 2
GM 23542
Manufacturer Contact
frank clanzett
moislinger allee 53-55
lubeck 23542
GM   23542
518822868
MDR Report Key2679619
MDR Text Key2776741
Report Number9611500-2012-00045
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK011404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/13/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/20/2012 Patient Sequence Number: 1
Treatment
NIHON KOHDEN PATIENT MONITOR
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