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

Catalog Number 8606000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device is approximately 5 years old and not under a service contract; the maintenance status is unknown.Dräger was seeking for additional information but the only aspect that could be obtained was that the device is back in use after exchange of a filter which was performed by the hospital's biomedical engineer.A case specific-evaluation is not possible due to lack of information.The device is equipped with a vacuum pump that generates an auxiliary vacuum pressure which is needed to actuate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.The system effect of an occluded inlet filter for the vacuum pump is that the pump cannot build-up the necessary pressure upon which the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.It is recommended by dräger to check the workstation in regular intervals.Inspection of the inlet filter and replacement based upon visual appearance are part of the service and maintenance procedure, a replacement of the filter shall be done at least every two years.Given that the reported issue "stopped working" can be considered a shutdown of automatic ventilation.This may have been caused by an occluded filter of the vacuum pump.If so, it is seen likely that the maintenance recommendations were not followed and finally led to the particular ventilator failure during use.A reliable conclusion about the root cause is however not possible based on the few confirmed facts.

Event Description

It was reported that the device "stopped working" during a running surgical procedure.No patient consequences have been reported.

• 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: 11130458
• MDR Text Key: 228229097
• Report Number: 9611500-2021-00005
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1