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

Model Number	8606500
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a vent fail during a case.There was no patient injury reported.
Additional Manufacturer Narrative
Based on the device log analysis for the reported date of event, the reported symptom could be reconstructed, and it was found that the supervisor function of the device detected a deviation of the motor and forced a shutdown of automatic ventilation.The shut-down was accompanied by a corresponding alarm.To prevent from potentially hazardous output and/or from damages to the ventilator unit, the device reacted in accordance with its implemented safety concept as it interrupted automatic ventilation, switched to man/spont mode and generated a corresponding audible and visible ventilator fail alarm.In such case both manual ventilation and monitoring functions will remain unaffected and available.Hence, the user can ventilate the patient manually and monitor relevant information regarding ventilation and gas delivery.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component.During on-site checking in follow-up to the event, the draeger service engineer could confirm the issue and consequently replaced the ventilator motor.After replacement, the device was tested and returned back to use without further problems reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: APOLLO
• Common Device Name: ANESTHESIA
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 23061303
• Report Number: 9611500-2025-00522
• Device Sequence Number: 18597578
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200806(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
• Report Date (Section B): 09/16/2025

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: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown