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

Catalog Number 8604700

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 12/26/2023

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 the device stopped ventilating in the middle of a surgical case.No injury reported.

Manufacturer Narrative

The investigation was performed based on the provided log files and the onsite examination of the affected fabius gs by the dräger service.Analysis of the log files showed that the device has shut-down automatic ventilation due to measured speed fluctuations at the ventilator.The vacuum pump and motor have been replaced by the dräger technician and were sent in for examination.The vacuum pump was found to work as specified but the motor was stuck at one position which was identified as root cause for the reported stop of ventilation.The affected motor is approximately 19 years old.Wear and tear of the collector disc may have caused the speed fluctuations during motor rotation.These speed fluctuations will result in deviations between the intended piston hub and the real one and, the applied tidal volumes will not match the settings.To prevent from potentially hazardous output the device is designed to shut down automatic ventilation and to post a corresponding alarm to alert the user.Manual ventilation and the monitoring functions remain available to the full extend which enables the user to finish the particular surgical procedure.After replacement of the ventilator motor and vacuum pump by dräger service the device was confirmed to be operating per manufacturer¿s specification.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after almost 19 years of use; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device stopped ventilating in the middle of a surgical case.No injury reported.

• 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: 18578440
• MDR Text Key: 334836701
• Report Number: 9611500-2024-00025
• 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: 02/16/2024

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: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2005
• 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