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	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The workstation was subject to an on-site evaluation by a dräger field service engineer who could confirm the reported issue and trace it back to an issue with the pump of the auxiliary vacuum.The device generates a vacuum pressure in a special pneumatic circuit which is needed to actuate the valves that control the ventilation cycles and to keep the diaphragm of the piston ventilator in place during ventilator operation.When the vacuum pressure is out of range, the valve actuation may be inhibited, and the piston diaphragm can become wrinkled.Consequently, to prevent from potentially hazardous device output and from severe mechanical damages to the ventilator unit, the device is designed to force a safety shutdown of automatic ventilation and to alert the user to this by means of a corresponding alarm.If this situation occurs, manual ventilation including gas dosage remains still possible.The vacuum pump was replaced; the device passed all consecutive tests and could be returned to use.It is finally concluded that the device responded as designed upon the underlying error condition.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 the device exhibited a ventilator failure during a running surgery.As per report, no health consequences for the patient resulted from the event.

• 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: 21117993
• Report Number: 9611500-2025-00021
• Device Sequence Number: 8732888
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)211007(17)220312(93)8607000-77
• Combination Product (Y/N): N
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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