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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device stopped ventilating during use.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The analysis was performed based on the submitted information including the electronic logfile of the device.The reported failure of the ventilator could be confirmed by means of the information stored in the log.The log entries indicate that the vacuum pressure that is required to keep the ventilator diaphragm in place was too low.The fabius reacted as specified for this situation- stopped the automatic ventilation and posted a corresponding alarm.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.The device was checked on-site by a draeger service technician.A worn rolling membrane was identified as root cause for the reported issue.It was further found that there were no records of a preventive maintenance with draeger brazil and that the preventive maintenance for this device was overdue since january 2019.As also described in the ifu, wear or material fatigue of the components is possible and to maintain the function of all components, the device must be inspected and serviced at the intervals specified.As further given in the ifu, inspection and service of the fabius gs premium needs to be performed every 12 months.Also, the checklist for daily checkout before using the device include to check that the maintenance intervals of the device and accessories have not been exceeded.Dräger finally concludes that the device behaved as specified upon the wear-related malfunction of a single component and alarmed accordingly to alert the user.Replacement of the affected component as well as the following of the ifu including preventive maintenance has been advised to the customer.In regard to the recommended replacement, no feedback has been received from the customer.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 stopped ventilating during use.There was no patient injury reported.

• 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: 22369335
• Report Number: 9611500-2025-00344
• Device Sequence Number: 8025502
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)190111(93)8607000-72
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2019
• 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