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

Model Number	8604700
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the course of the investigation, it became apparent that during the case in question a ventilator failure occurred and thus the case was assessed reportable retrospectively.The log file analysis indicates that the piston movement of the ventilator was temporarily stopped during the concerned procedure due to a negative airway pressure measured.As the dispatched fse could neither duplicate the error condition nor find any hints of a device malfunction it can be assumed that the triggering condition was not device-related; a reasonable explanation would be the use of a bronchial suction system or patient activity.Based on experience a sticking auxiliary air intake valve may have caused that a fresh gas deficit could not be compensated by device countermeasures that would be initiated when the airway pressure becomes negative.A sticking auxiliary air intake valve can be the result of insufficient reprocessing.Dräger finally concludes that the device reacted as designed upon an error condition of unknow.
Event or Problem Description
It was reported that the vt readings dropped very low during a case.The patient was ventilated manually for a short bit before mechanical ventilation was continued.It reportedly worked for a short time and then the readings went very low again.No injury reported.

• Brand Name: FABIUS GS
• 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: 20416635
• Report Number: 9611500-2024-00433
• Device Sequence Number: 8209158
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)180806(17)190130(93)8607000-71
• Combination Product (Y/N): N
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2008
• 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