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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
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
Event Description
It was reported that a ventilator failure occurred during use of the device. As per report, this did not lead to consequences for the patient.
 
Manufacturer Narrative
The device is not under a service contract. The hospital's biomed was seeking dräger's assistance in follow-up of the event and, based on the error codes he had found in the log file, the ventilator motor was identified as the causer for the vent fail. The motor was replaced; the device passed all consecutive tests and was returned to use w/o further problems reported to date. The device was manufactured in the year 2004. The log file entries indicated that the supervisor function has detected speed fluctuations during ventilator motor operation. Wear and tear of the collector disc after more than 17 years of use may have caused the speed fluctuations during motor rotation. These speed fluctuations will result in deviations between the intended piston hub and the real one and, the applied tidal volumes will not match the settings. To prevent from potentially hazardous output and/or from mechanical damages to the ventilator unit the device is designed to shut down automatic ventilation and to post a corresponding alarm to alert the user. Manual ventilation with the built-in breathing bag remains possible in this state. Dräger finally concludes that the device behaved as specified for the specific error condition; no patient consequences occurred. 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 Key13947755
MDR Text Key297319068
Report Number9611500-2022-00069
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 Other Health Care Professional
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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