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

Model Number	8606500
Medical Device Problem Codes	Decrease in Pressure (1490); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the mechanical ventilator didn't seem to be ventilating as per what clinician expected based on settings.They were able to bag the patient without issue.No patient injury.
Event or Problem Description
It was reported that the mechanical ventilator didn't seem to be ventilating as per what clinician expected based on settings.They were able to bag the patient without issue.No patient injury.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.No malfunction was found.The described symptom was caused by a leakage in the patient circuit.In case of decreased tidal volume and/or airway pressure, e.G.Caused by a significant circuit leak, the sufficient ventilation and oxygenation of the patient might be restricted.During power-on self-test (post) and standby leak test as well, internal and external leakages are detected and depending on size a conditional (yellow) or non-functional (red) state is the consequence.Based on leakage, fresh gas flow settings and set alarm limits during ventilation several audible and visible alarms would be issued (e.G.Apnea, minute volume low, volume/pinsp not attained).All alarms, possible causes and remedies are described in the instructions for use.The case has been assessed to be not reportable in accordance to mdr.

• 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 ; 4518822868
• MDR Report Key: 23801274
• Report Number: 9611500-2025-00688
• Device Sequence Number: 9334336
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)211222(17)260414(93)8606500-68
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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