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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.
 
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Brand NameFABIUS TIRO
Type of DeviceANESHESIA 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 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
0 Patients were 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
Device Catalogue Number8606000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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