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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was just startet, the result will be forwarded as soon the investigation is completed.

Event Description

It was reported during a case the unit displayed a ventilator failure.The unit was switched to manual mode and the case was completed.There was no patient injury reported.

Event Description

It was reported during a case the unit displayed a ventilator failure.The unit was switched to manual mode and the case was completed.There was no patient injury reported.

Manufacturer Narrative

The logfile was available for investigation and revealed entries indicating a stopped and stalled ventilator motor.Since the found entries could be caused by several root causes, e.G.An issue with the motor itself, issues with the light barrier, the incremental encoder or the control pcb, it was recommended to the draeger organization in the us to have a draeger technician to analyze and fix the root cause.Replaced parts were also requested for an in-depth analysis.However, as further reported, the service was still not completed.Thus, the exact root cause could not be finally determined.Checking the ventilator operation is part of the daily and pre-use check (described in the instruction for use) and must be carried out before each patient use.Based on the given information, it can be concluded that the ventilator failure was related to the aspect that the supervisor function of the fabius system detected an issue that forced a shut-down of automatic ventilation according to its safety concept.Such a ventilator shutdown is accompanied by the corresponding vent fail alarm.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14082738
• MDR Text Key: 297361049
• Report Number: 9611500-2022-00096
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2008
• 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