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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS MRI; ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA FABIUS MRI; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607300
Device Problems Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the device posted a ventilator failure during use.There was no injury reported.
 
Manufacturer Narrative
The device was inspected on-site by a dräger service engineer who confirmed the reported issue of ventilator failure and replaced the ventilator motor unit upon the findings of initial log file analysis.The device passed all required tests afterwards and could be returned to use.The replaced motor unit was returned to the manufacturer for an in-depth analysis.Visual examination revealed that the piston was blocked at the lower end.Root cause could be traced back to a damaged incremental encoder sensor - as a result from this error condition the software could not recognize the rotation of the motor anymore and the piston was moved towards the lower end position and remained blocked there.This particular failure mode was never observed before in comparison to more than 100.000 devices sold.If automatic ventilation fails the device posts a corresponding alarm to alert the user.Manual ventilation remains possible then.
 
Event Description
Please refer to initial mfr.Report #9611500-2020-00259.
 
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Brand Name
FABIUS MRI
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key10319007
MDR Text Key200437378
Report Number9611500-2020-00259
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041498
UDI-Public(01)04048675041498(11)160909(17)170228(93)8607300-42
Combination Product (y/n)N
PMA/PMN Number
K072884
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 06/23/2020,08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8607300
Was Device Available for Evaluation? No
Date Report to Manufacturer06/23/2020
Date Manufacturer Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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