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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS PLUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA FABIUS PLUS; ANESTHESIA UNITS Back to Search Results
Catalog Number 8606800
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
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 the operator observed during use that the device posted error messages and stopped the ventilation.As per report, the device was replaced in a controlled maneuver; no patient consequences have occurred.
 
Event Description
It was reported that the operator observed during use that the device posted error messages and stopped the ventilation.As per report, the device was replaced in a controlled maneuver; no patient consequences have occurred.Remark: dräger has received a user facility report for this incident after having filed the initial report to the authorities.The ufr states that the vent fail led to a delay in surgery which must be considered a serious injury in the meaning of the reporting regulations.Thus, the case has been re-classified from "product problem" to "adverse event and product problem".
 
Manufacturer Narrative
The dispatched engineer from the local dräger s&s organization could confirm the reported aspect of ventilator failure and replaced the entire ventilator unit at the workstation.It was verified by the applicable tests that this has put back the device into fully operable condition.The replaced motor was returned to the manufacturer and subject to an in-depth investigation in the manufacturer's lab.It could be determined that wear-and-tear related abrasion of the collector disc had resulted 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.The speed fluctuations result in a deviation between measured and expected piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, 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 with the built-in breathing bag including gas dosage remains further possible.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component.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 Name
FABIUS PLUS
Type of Device
ANESTHESIA 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
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key18099918
MDR Text Key327713811
Report Number9611500-2023-00400
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041481
UDI-Public(01)04048675041481(11)201125(17)210307(93)8606800-74
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 01/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8606800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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