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

Catalog Number 8607300

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

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

A vent fail during use was reported.No patient injury reported.

Event Description

A vent fail during use was reported.No patient injury reported.

Manufacturer Narrative

A logfile has not been provided for further investigation.The investigation was carried out based on the available information.According to the described event, there was a membrane pressure low error.This vacuum pressure is needed to keep the diaphragm of the ventilator in place to avoid wrinkling during piston movement.If significant deviations are detected the software forces a shutdown of automatic ventilation to prevent from serious mechanical damages to the ventilator unit.This shutdown is accompanied by a corresponding alarm; manual ventilation and the monitoring functionalities remain available.There are several plausible root causes for such an issue with the vacuum pressure.A puncture of the piston diaphragm, a leak in the assembly of the dedicated pneumatic circuit, leaks inside the pump, pump calibration error etc.This expertise was transmitted to the dispatched technician who reportedly performed some intervention at the anesthesia workstation and get it back working.The device was tested and confirmed to be operating per manufacturer's specifications and was returned to use without further problems reported.It is not exactly known which measure was the one that rectified the problem.Hence, a clear root cause cannot be assigned by dräger.It can however be concluded that the workstation responded as designed upon a deviation in one of the subsystems.There was 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: 18054117
• MDR Text Key: 327126111
• Report Number: 9611500-2023-00390
• 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: 05/07/2024

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: 8607300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2006
• 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
• Treatment: NA.; NA.