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

Catalog Number 8604700

Device Problems Degraded (1153); Failure to Deliver (2338); No Pressure (2994)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that a ventilator failure occurred during a case.No patient injury reported.

Event Description

It was reported that a ventilator failure occurred during a case.No patient injury reported.

Manufacturer Narrative

The device logfile was made available for evaluation."motor stalled" and "motor slow" entries were found during the reported date and time of event.The root cause can be manifold.During on-site checking in follow-up of the event, the draeger technician replaced the ventilator motor and the light barrier cable.Unfortunately, the parts were not available for investigation at manufacturer's site.Thus, the exact root cause could not be determined.In general, the device monitors the speed, rotation angle and other performance parameter of the motor continuously.Any speed fluctuations or other deviations may result in a divergence between expected piston position and the real hub that has been performed.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.In case automatic ventilation is shut-down manual ventilation and monitoring functions remain available.As the exact root cause could not be determined, a corresponding risk assessment is not possible.However, based on the performed investigation, draeger concludes that the device behaved as specified upon the detected stalled/slow motor and alarmed accordingly.There were no patient consequences reported.As further reported from the technician, the replacement of the parts fixed the reported symptom.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17029280
• MDR Text Key: 316216877
• Report Number: 9611500-2023-00203
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: 10/17/2023
• 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