• 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 TIRO; 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 TIRO; ANESTHESIA UNITS Back to Search Results
Catalog Number 8606000
Device Problems Use of Device Problem (1670); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation has been started; results will be provided within the follow-up report.
 
Event Description
It was reported that the device failed during use.There was no injury reported.
 
Manufacturer Narrative
As further clarified with the user in the course of investigation, it was confirmed that the case in question did not occur on 2022-07-21 but 2022-07-15.Based on the provided logfile, no entries were found that are related to the reported device failure.Finally, as the reported event could not be comprehended, the root cause of the reported symptom could not be determined.On the basis of the information available, the case is classified as non-serious incident and if investigation results were known before, the case would not have been rated reportable.In general, if automatic ventilation stopped, the device would post a corresponding alarm to inform the user about the situation.In any case, manual ventilation and spontaneous breathing is still be possible in switched-off state.
 
Event Description
It was reported that the device failed during use.There was no injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FABIUS TIRO
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key15468835
MDR Text Key306089296
Report Number9611500-2022-00242
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/20/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2022
Initial Date FDA Received09/22/2022
Supplement Dates Manufacturer Received12/07/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-