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

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.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA 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 Key: 11347502
• MDR Text Key: 232514031
• Report Number: 9611500-2021-00077
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1