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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 No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided within a follow-up report.
 
Event Description
It was reported that at the beginning of the operation the device worked normally.But later on the device reportedly has posted an alarm and displayed "could not work normally." the user switched to manual ventilation.No injury reported.
 
Manufacturer Narrative
The investigation was performed based on the available device log file.As the exact date of the event could not be provided anymore the complete log file was reviewed finding the error code v045 "membrane pressure high" which is connected to the reported symptom.This event is logged when the membrane vacuum exceeds the maximum value of ¿ 250mbar for automatic ventilation.The vacuum pressure is required to keep the ventilator membrane in place during piston movement.If the device detects a significant deviation between measured value and target value, the ventilator stops working as a precautionary measure and shuts down the automatic ventilation accompanied by an audible alarm and a visible alarm message "ventilator fail".Switching to manual ventilation is possible and monitoring is still functional.Additional information was received that the device was not maintained by the hospital within the required service interval and that the filter of the vacuum pump was found to be blocked.As after cleaning of the filter the device worked normally a blocked filter of the vacuum pump was determined to be root cause of the reported problem.The affected fabius is 10 years old and the respective filter is part of the yearly service procedure.The fabius has reacted as specified for the detected situation and has posted appropriate alarms to inform the user.
 
Event Description
Please refer to the initial-report.
 
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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 
MDR Report Key9334310
MDR Text Key178148972
Report Number9611500-2019-00387
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
Type of Report Initial,Followup
Report Date 12/20/2019
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
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/18/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NA.; NA.
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