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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.
 
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Brand NameFABIUS GS PREMIUM
Type of DeviceANESTHESIA 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
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 Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
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