• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607000
Device Problems No Pressure (2994); Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2019
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 during the operation, the ventilation failed.The device posted an alarm and switched to manual ventilation.No injury reported.
 
Manufacturer Narrative
Further information as e.G.Log file and service report were requested for investigation at manufacturing site.Unfortunately no additional information was received so that no investigation could be performed and that finally no root cause could be determined explaining the reported symptom.In general in case of a ventilator failure automatic ventilation is not possible anymore.The device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The fabius is equipped with an integrated pressure- and volume-monitoring.
 
Event Description
Please refer to the initial-report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FABIUS GS PREMIUM
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9381111
MDR Text Key182190371
Report Number9611500-2019-00399
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041467
UDI-Public(01)04048675041467(11)190123(17)190623(93)8607000-72
Combination Product (y/n)N
PMA/PMN Number
K011404
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 01/15/2020
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 Number8607000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/08/2019
Initial Date FDA Received11/27/2019
Supplement Dates Manufacturer Received01/09/2020
Supplement Dates FDA Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-