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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS TIRO ANESTHESIA UNITS Back to Search Results
Catalog Number 8606000
Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2022
Event Type  malfunction  
Event Description
It was reported that the device shut down during use. The case was completed with a replacement device. There was no injury reported.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Search Alerts/Recalls

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Brand NameFABIUS TIRO
Type of DeviceANESTHESIA 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 Key15291485
MDR Text Key303250038
Report Number9611500-2022-00217
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2009
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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