MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Apollo; Anesthesia Units

Model Number	8606500
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device posted a "ventilator failure" alarm during use.There was no injury reported.
Event or Problem Description
It was reported that the device posted a "ventilator failure" alarm during use.There was no injury reported.
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided in a separate follow-up-report.
Additional Manufacturer Narrative
The ventilator failure described by the user could be reconstructed by means of the log file analysis.No indications of a device malfunction were found.Root cause for the reported symptom was an overpressure at the patient end of the circuit leading to a pressure peak.It can be assumed that a patient coughing against the ventilator caused the pressure peak.To prevent damage, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device responded as specified upon the detected situation with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• Brand Name: Apollo
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; +49(451)8822868
• MDR Report Key: 50294193
• Report Number: 9611500-2026-00418
• Device Sequence Number: 9732206
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2015
• 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