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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 Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2019
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 during anesthesia, the device did not ventilate.There was no patient injury reported.
 
Manufacturer Narrative
It was reported that the device ceased to ventilate during a surgical procedure.Reportedly the users introduced a replacement device and mentioned explicitly that no consequences to the patient have occurred.Dräger asked for further information but there was however none provided.Evaluation and assessment had to be done based on the initial description.The failure mode cannot be understood due to lack of information.In fact, it can even not be confirmed that a device problem has occurred - the presence of a large leakage in the patient circuit outside the device may also result in a significant decrease of gas flow at the patient opening and may lead to the perception that the device stopped to ventilate.The fabius tiro is equipped with integrated pressure-, volume- and o2-monitoring.A dedicated alarm will be generated if one measured value is out of adjusted alarm limits (insp pres not reach !!, apnea pressure !!!, apnea flow !!! etc.).Furthermore, patient gas monitoring is mandatory for anesthetic procedures allowing a constant overview of the gas exchange and efficacy of anesthesia.
 
Event Description
Please refer to initial mfr.Report # 9611500-2019-00394.
 
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Brand Name
FABIUS TIRO
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9374133
MDR Text Key176856165
Report Number9611500-2019-00394
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 01/23/2020
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 Number8606000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received01/06/2020
Supplement Dates FDA Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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