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

Catalog Number 8607300

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The auxiliary vacuum pressure is needed to operate the valves in the cosy 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.The event dates back to (b)(6) 2020 and, there was neither a log file nor other relevant information available.The device is not under a service contract.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.Similar cases are known in isolated numbers and their investigation mostly revealed that the maintenance recommendations were not followed.It is seen likely that this explanation applies for the particular case as well.

Event Description

It was reported that the device suddenly alarmed during use and stopped automatic ventilation; the issue did not lead to patient consequences.It was further reported that the device was inspected by a third-party service provider and that the issue could be traced back to an occluded inlet filter of the vacuum pump.

• Brand Name: FABIUS MRI
• 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: 11264626
• MDR Text Key: 245094708
• Report Number: 9611500-2021-00044
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: No
• Device Age: 7
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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