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

Model Number	8607000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unit had a vent failure during use.No patient injury.
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded once the investigation is closed.
Additional Manufacturer Narrative
The investigation was carried out based on the available information and the analysis of the provided logfile.The log entries indicate that the vacuum pressure, that is required to keep the ventilator diaphragm in place, was too low.The software monitors several parameters that are relevant for a safe automatic ventilation, amongst others the membrane pressure (internal diaphragm vacuum).The fabius reacted as specified for this situation - stopped the automatic ventilation and posted a corresponding ventilator fail alarm.In this case, fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag each fabius is equipped with.There are several plausible root causes for such an issue with the vacuum pressure.During on-site checking in follow-up to the event the service technician found a small hole in a hose near the cosy apl valve, which possibly had an effect on the pressure in the system.The affected part was removed and was not available for the investigation, therefore it was not possible to determine an exact root cause.The device got tested and operation according to manufacturer's specification was confirmed.Dräger finally concludes that the fabius in question behaved as specified upon the detected deviation by shutting down automatic ventilation and alerting the user by means of a corresponding alarm.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 or Problem Description
It was reported that unit had a vent failure during use.No patient injury.

• Brand Name: FABIUS GS PREMIUM
• Common Device Name: 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: 20118238
• Report Number: 9611500-2024-00367
• Device Sequence Number: 7221484
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)181109(17)190504(93)8607000-72
• Combination Product (Y/N): N
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown