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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS Back to Search Results
Model Number 8607000
Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946); Activation Failure (3270)
Patient Problem Insufficient Information (4580)
Event Date 08/06/2021
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 there was a ventilator failure leading to a prolonged anesthetic induction with consequent laryngeal and bronchospasm.Reportedly medical intervention was necessary.It was further reported, that the patient had already been discharged from the hospital without further consequential injuries reported.Based on the preliminary logfile analysis, it was found that the pre-use test and leakage test were not passed before the case.As also described in the ifu, the pre-use checkout must be performed to ensure that the device is ready for operation.It is in the responsibility of the user to use a device in a non-functional state.
 
Manufacturer Narrative
The electronic device logfile was available for investigation.Despite the initial report of the user, there were no indications for a ventilator failure found in the logs.Thus, the correctness of the reported date of event was checked and confirmed.On the date and time of event, only three entries were found indicating that the system leak test and patient circuit leak test failed due to high leakages.As further reported by the hospital staff, there was a leakage found on the trachea of the balloon before the operation and was reportedly eliminated.However, also after the case in question, entries of failed leakage tests were found.It can finally be concluded that there were no indications for a device malfunction found that could be brought in causal connection to the reported symptom.The reported ventilator failure could not be confirmed based on the log analysis.Only entries were found indicating that the pre-use test and leakage tests were not passed before the case.It was additionally reported that the case took place between 02:35pm and 05:10pm and it was confirmed that the fabius¿ date and time was equal to real time.According to the log analysis, the system leak tests and patient circuit leak test failed at 02:38pm as well as 02:42pm.Thus, it is imaginable that it was assumed by the staff that the leakage at the trachea of the balloon was the root cause for the failed test, but a subsequent performed test was also not passed successfully.The fact of the failed leakage tests at the end of the case strengthen this assumption that the real leakage was not fixed prior to use.As also described in the ifu, the pre-use checkout must be performed to ensure that the device is ready for operation.It is in the responsibility of the user to use a device in a non-functional state.
 
Event Description
It was reported that there was a ventilator failure leading to a prolonged anesthetic induction with consequent laryngeal and bronchospasm.Reportedly medical intervention was necessary.It was further reported, that the patient had already been discharged from the hospital without further consequential injuries reported.Based on the preliminary logfile analysis, it was found that the pre-use test and leakage test were not passed before the case.As also described in the ifu, the pre-use checkout must be performed to ensure that the device is ready for operation.It is in the responsibility of the user to use a device in a non-functional state.
 
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Brand Name
FABIUS GS PREMIUM
Type of Device
ANESTHESIA UNITS
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key12517824
MDR Text Key273772911
Report Number9611500-2021-00397
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041467
UDI-Public(01)04048675041467(11)190823(17)200205(93)8607000-75
Combination Product (y/n)N
PMA/PMN Number
K011404
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 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8607000
Device Catalogue Number8607000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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