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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESHESIA UNITS

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DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESHESIA UNITS Back to Search Results
Catalog Number 8606000
Device Problems Gas Output Problem (1266); Improper Flow or Infusion (2954); Pressure Problem (3012); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 05/26/2021
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, the device posted a ventilator failure alarm.The patient was manually ventilated while changing to spare device.No injury reported.
 
Manufacturer Narrative
A dräger service engineer was dispatched who could confirm the reported issue and narrow it down to an issue with the auxiliary vacuum pressure.He replaced the vacuum pump and the device could be returned to service afterwards.The auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the pump cannot build-up the necessary pressure the device is designed to shut down automatic ventilation to prevent from potentially hazardous output and to avoid serious mechanical damages that may arise from a piston diaphragm that gets wrinkled.Dräger finally concludes that the device has detected the deviation and brought it to the user's attention by means of a corresponding alarm.The field failure rate of the vacuum pump is inconspicuous.
 
Event Description
It was reported that during use, the device posted a ventilator failure alarm.The patient was manually ventilated while changing to spare device.No injury reported.
 
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Brand Name
FABIUS TIRO
Type of Device
ANESHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
MDR Report Key12007603
MDR Text Key259623730
Report Number9611500-2021-00259
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 company representative,user f
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
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
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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