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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS GS ANESTHESIA UNITS Back to Search Results
Catalog Number 8604700
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/22/2022
Event Type  malfunction  
Event Description
It was reported during a case the unit alarmed for a ventilator failure. There was no patient injury reported.
 
Manufacturer Narrative
Upon checking the device on-site, the dispatched dräger service engineer identified problems with the ventilator motor and replaced it, consequently. The device passed all consecutive tests and could be returned to use. An in-depth evaluation of the replaced motor was not considered necessary because the failure mechanism was evaluated in detail during earlier complaint investigations with the same nature: wear-and-tear related abrasion of the collector disc results in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence. These speed fluctuations may result in a deviation between intended and expected piston position. To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm. Manual ventilation and the monitoring functions remain available to the full extend which enables the user to finish the particular surgical procedure. Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after approx. 17 years of use; no patient consequences have been reported. The repair exchange has fully solved the device problem. The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand NameFABIUS GS
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 Key14630252
MDR Text Key297537218
Report Number9611500-2022-00139
Device Sequence Number1
Product Code BSZ
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 Biomedical Engineer
Type of Report Initial
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8604700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2005
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: 06/08/2022 Patient Sequence Number: 1
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