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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS TIRO ANESTHESIA UNITS Back to Search Results
Catalog Number 8606000
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
A log file was provided for evaluation but since the event was reported with more than 3 months delay to (b)(4), the user facility was unable to provide additional information regarding the course of event. The log file indicates that mains power was lost twice on the date of event; the device continued operation on battery each time until mains power was restored. Two instances of switching the device on were recorded for the respective day. No clear indication for the potential presence of a device malfunction could be found. The missing exact time of event and the brief description makes it difficult to interpret the logs. If mains power gests lost for whatever reason the device will indicate via alarm message that the internal battery is activated. Residual capacity is being displayed continuously and, alarms will be posted as soon as the remaining battery load underruns 20% and 10%, respectively. In the particular event, mains power was restored each time before this stage of depletion was reached. The second switch-on may have been related to user interaction but also to technical issues with the mains switch, the power supply or other aspects; without examination of the device is no reliable conclusion possible. The intended use of an anesthesia workstation requires that the device is being operated under constant supervision of a trained user - it could not be clarified why the supposed shut down was not noticed before the patient monitor alarmed for desaturation; if the display of the device blanks out for a software-triggered reboot, start-up sequence or other reasons this is clearly recognizable for the operator. It is evident that, with the exemption of the short interruption during the second start-up, ventilation was continued. Manual ventilation with the built-in breathing bag would however always be possible ¿ even if the device is switched-off. Based on the available information, no explanation for the reported observation can be found.
 
Event Description
It was reported that the patient monitor which was additionally used alarmed for decreased oxygen saturation of the patient. Reportedly, the users became aware that the anesthesia workstation had shut down and restarted. The anesthesia device was replaced; no patient consequences have occurred.
 
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Brand NameFABIUS TIRO
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11347502
MDR Text Key232514031
Report Number9611500-2021-00077
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2011
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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