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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS MRI ANESTHESIA UNITS Back to Search Results
Catalog Number 8607300
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
During an internal review it was determined that the log entry "m006" which was found in the device log file is connected to a ventilator failure so that thereby the case is reportable. The dispatched dräger technician was unable to duplicate the reported symptoms. The log file analysis revealed that the airway pressure went into very negative range (less than -10 mbar) during active ventilation mode. This causes the software to stop the ventilator and to alarm for a vent failure as long as the pressure remains below -10mbar. In this case automatic ventilation is not possible. The user can switch to manual ventilation as described in the instructions for use. In this situation, monitoring is still functional. As soon as the patient airway pressure is above -10 mbar again, the alarm will disappear and the fabius will restart automatic ventilation. If the pressure drops below -10 mbar this will trigger the opening of the auxiliary air valve for additional intake of ambient air. The reported issue could be explained with a sequence of two contributing factors to which the device has responded: the patient may have taken a breath at this time leading to negative pressure and the auxiliary air valve did not open for unknown reason, probably due to improper cleaning. The device behavior was exactly as per definitions of the safety concept - (temporary) shutting down of automatic ventilation and alerting the user to this condition. The device was tested afterwards and passed all tests and is back in use without further problems reported since then.
 
Event Description
It was reported that during a case automatic ventilation stopped working and the machine alarmed. The case was completed and there was no patient injury reported.
 
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Brand NameFABIUS MRI
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8123693
MDR Text Key129591605
Report Number9611500-2018-00383
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue Number8607300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2012
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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